Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. Summary: Using EH&S, Inspection Management and project management expertise within the drug development industry, the Manufacturing Project Manager serves as the manufacturing representative across functions and Regeneron locations, to manage EH&S and Inspection Management activities within Manufacturing. Level to be determined based on qualifications relevant to the role Essential Duties and Responsibilities include, but are not limited to, the following: Applies understanding of EH&S and Inspection Management principles, concepts, techniques and standards. Administers effective, accurate, and timely communication across functional areas and Regeneron locations, serving as a primary point of contact for Manufacturing EH&S and Inspection Management related activities. Utilizes tools and mechanisms to ensure global alignment of commercial manufacturing's processes, procedure and methods. Participates in regulatory inspections and internal audits as the primary point of contact for manufacturing Trains and coaches SME's and coordinators for inspections Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Involved in daily operational activities including process area walkthroughs. Works with Environmental Health and Safety group to track near misses, incident reports and hazard recognition and drive for resolutions. Knowledge and Skills: Excellent writing and editing skills. Strong attention to details. Ability to effectively communicate issues and ideas with peers and with management. Ability to build effective working relationships throughout the organization. Ability to facilitate meetings with cross-functional teams. Ability to operate independently within a tight deadline environment. Is a high energy self-starter with a resilient, can-do attitude. Ability to adapt to a quickly changing environment. Education and Experience: • Requires BS/BA degree with a minimum of 5 years of relevant experience. • Relevant experience may be substituted in lieu of educational requirement. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-DR1
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. *This is a 1st shift, Monday-Friday position Summary: This position will report into Manufacturing to provide leadership and direction for clean room contamination control in support all manufacturing programs; including, but not limited to the manufacturing process and associated clean utilities, qualification and validation activity, microbial sampling/testing practices, data trending, and investigations. Oversees the Manufacturing microbial control for commercial manufacturing production in addition to implementation of improvements. The level will be determined based on education and experience. Essential Duties and Responsibilities include, but are not limited to, the following: • Ensures that all manufacturing clean room controls are in compliance with cGMP guidelines and applicable regulations • Reviews and provides feedback on area procedures, including SOP's, master batch documentation, change controls, and validation protocols/reports in accordance with cGMP standards • Chairs reoccurring and ad-hoc cross functional teams in support of manufacturing microbial control initiatives • Documents and investigates quality events associated with contamination control of commercial manufacturing to ensure effective root-cause analysis, corrective action plans determination, product impact, and remediation. • May develop and deliver microbial control training • Prepares reports and metrics by collecting, analyzing, and summarizing information and trends • Makes decisions; develops and implements policies • Implements preventive and corrective actions to enhance clean room controls • Participates in regulatory inspections and any required follow up actions • Ability to foster working relationships between multiple departments of Regeneron in support of bulk manufacturing microbial control efforts Education and Experience: • Bachelors degree in Microbiology, Medical Technology, Biology or related field and 5+ years of relevant cGMP manufacturing experience. • Knowledge and experience in pharmaceutical microbiology, cell culture manufacturing, clean utilities, clean room design and operations, and microbial sampling and testing techniques. • Senior Specialist requires Bachelors degree in Microbiology, Medical Technology, Biology or related field and 5+ years of relevant cGMP manufacturing experience. • Principal Specialist requires Bachelors degree in Microbiology, Medical Technology, Biology or related field and 8+ years of relevant cGMP manufacturing experience. Knowledge, Skills, & Abilities: • Ability to maintain integrity and honesty at all times • Ability to work independently or as part of a team • Ability to communicate with transparency • Continuously drive to improve processes for improved performance • Demonstrate respectful behavior at all times • Ability to multi-task • Ability to analyze and identify trends • Develops and delivers effective presentations • Problem-solving skills • Ability to train others on basic systems and processes • Strong written communication • Ability to work in an ever-changing environment • Critical thinking skills This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
The Regeneron Genetics Center (RGC) is a wholly-owned subsidiary of the Company, whose goals are to apply large scale human genetics to identify new drug targets and to guide the development of therapeutics programs and precision medicine. Building upon Regeneron's strengths in mouse genetics and genetics-driven drug discovery and development, the RGC specializes in ultra-high-throughput exome sequencing, large scale informatics and data analysis encompassing genomics and electronic health records, and translating genetic discoveries into new biology and drug discovery opportunities. The RGC leverages multiple approaches including large population based studies, Mendelian genetics and family based studies, founder population genetics, and large-scale disease focused projects and has developed a network of over 50 collaborations with research organizations around the world. Including some of the largest sequencing studies in the world, such as the DiscovEHR study in collaboration with Geisinger Health System, and an initiative to sequence 500,000 participants with the UK Biobank, the RGC has built one of the largest human genetics databases, including sequence data from over several hundred thousand participants and rapidly growing. Our interests encompass a breadth of different areas across all therapeutic areas and the RGC is highly integrated into all facets of research and development at Regeneron. Program goals include target discovery, indication discovery, and patient-disease stratification. Objectives include advancing basic science around the world through public sharing of discoveries, providing clinically-valuable insights to physicians and providers of collaborating health-care systems, improving patient outcomes, and identifying novel targets for drug development. Summary: We are looking for a talented Human Genetics scientist to join our Cardiovascular, Metabolic and Musculoskeletal Therapeutic Area Genetics team. The position will take on responsibilities for the design, execution, and interpretation of genetics studies focusing on cardiovascular, metabolic, and musculoskeletal diseases, as part of the Therapeutic Area Genetics team. The post holder will work closely with Clinical Informatics, Analytical Genomics and other teams in the Regeneron Genetics Center. Primary responsibilities will be to lead genetics discovery projects, support new programs and collaborations, and to support the execution of overall scientific strategy in cardiovascular, metabolic and musculoskeletal disease genetics. Goals of the team will be to apply genetics to target discovery, select indications for drug programs, and identify subgroups of patients who are more likely to respond to treatment through genetic analyses. Responsibilities: • Work with a multidisciplinary genetics team consisting of human genetics scientists, bioinformaticians, statistical geneticists, and other team members to design, execute, and interpret genetics studies related to in cardiovascular, metabolic and musculoskeletal diseases for the RGC. • Work in close collaboration with other Therapeutic Area Genetics team members and form a strong partnership with Analytical Genomics, Clinical Informatics and other RGC teams to deliver on complex, top-quality scientific endeavors in these Therapeutic Areas. • Generate, summarize, and present results in internal and external meetings to a variety of audiences. Lead or contribute to the writing of scientific reports and publications. • Represent the Therapeutic Area Genetics team in cross-functional initiatives within RGC and Regeneron. • Collaborate with external industry and academic partners in scientific consortia. Requirements: • PhD in Genetic Epidemiology, Statistical Genetics (with an applied focus), Human Genetics or similar with good analytical skills. • 2-4 years of experience or corresponding level of achievement in the field of large-scale human genetics post PhD. • Demonstrated ability to design and lead human genetics studies delivering novel genetic findings and medically relevant gene discoveries in a team-based environment. • Familiarity and experience with different genetic association approaches including GWAS, exome or genome sequencing in cohort, case-control or family-based studies. Ability to use large genetic datasets such as UK Biobank or other large biobanks, TOPMed, GWAS summary statistics, GTEx or similar. • Familiarity and experience with the applications of statistical genetics to gain medically-actionable insights, including conditional analyses, fine-mapping, quantitative traits analyses and Mendelian randomization. Ability to analyze complex loci, use gene-specific and genome-wide polygenic scores, or perform genetic studies that simulate randomized controlled trials. • An outstanding candidate will have experience with the use of genetics in combination with other "omics" technologies (eg. metabolomics, proteomics, RNA-seq). • Familiarity with command line interface, programming languages and statistical software (eg. Python, R, STATA), statistical genetics tools (eg. PLINK) and large-scale data platforms (eg. DataBricks, Scala). • Interest in understanding the genetic basis and causes of Cardiovascular, Metabolic and Musculoskeletal diseases and translating this knowledge into therapeutic insights. An outstanding candidate will have previous experience with cardiovascular, metabolic or musculoskeletal phenotypes. • Ability to work in a highly interactive environment with a diverse team of colleagues. • Outstanding communication skills and an ability to summarize and present the results of human genetic studies to a variety of audiences. • A commitment to high-quality science and to the highest standards of research and work ethics and integrity This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: The Temp - Senior Scientific Recruiter will partner with internal colleagues to design and deliver recruitment strategies and conduct high volume full-cycle recruitment activities to ensure successful Talent Acquisition from a technical and cultural perspective. This is an onsite role based in our Tarrytown, NY location. Responsibilities: Reporting to the Talent Acquisition Manager, specifically, she/he will: • Supporting, but not limited to, Clinical Development, Research & Development, Regulatory Affairs. Work independently to source, identify, qualify and deliver candidates for assigned client group, including senior-level positions, using a variety of creative recruiting methods. • Partner with R&D / Clinical Development hiring managers and HR within a highly matrix environment to identify and clarify job specifications in order to effectively generate top quality candidates. • Use experience and judgment to navigate complex situations • Work closely with Talent Acquisition Leadership, hiring managers and external partners to understand the needs of the business and develop a recruitment strategy to support current hiring and future growth. • Establish and/or maintain effective relationships with hiring managers, HR business partners, candidate pool, and Talent Acquisition team member; influencing best practice recruitment processes and strategies • Establish and execute full-cycle sourcing strategies utilizing your knowledge and understanding of recruitment principles and best practices to obtain results. • Uses traditional and nontraditional resources, such as career fairs, online job board, community networking events, social media, etc., to identify and attract quality candidates. • Manage current candidate activity in the applicant tracking system (ATS); suggests alternate recruiting methods as appropriate. Requirements: • Bachelor's Degree required • Experience recruiting within one or any of the following areas: Research & Development, Genetics, Clinical Development, Pharmaceutical/Biologics Manufacturing, MD, Scientific recruiting • A strong process orientation with the goal of implementing or developing best practices into the talent acquisition function. • 6+ years Talent Acquisition experience with demonstrated success in sourcing and hiring talent. • Ability to develop and execute recruiting strategies to meet staffing goals and objectives in a dynamic environment. • Excellent interpersonal and communication skills with a strong ability to establish and maintain effective relationships. • Ability to influence goals, objectives and deadlines in a dynamic and fast paced environment • Ability to influence on the overall objectives and long-range goals of the Talent Acquisition organization. Additional Preferences: • Strong process orientation, client focus and commitment to continuous improvement; ability to proactively network and establish effective working relationships with customers, candidates and schools. Candidate should have leadership and project management skills as demonstrated through previous work. They must work well with a team environment. Data analysis and event management experience is required. • The ideal candidate needs to be extremely organized with high level time-management skills, the ability to learn quickly with follow-through skills, be flexible, and have a high attention to detail. They will need excellent written and verbal communication skills, as well as an aptitude for public speaking and presenting. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: The Senior Manager, Talent Acquisition for Scientific Recruitment is responsible for recruiting senior level roles for and leading a team of TA Specialists and external TA partners, supporting key business units and building a strong TA team to support various disciplines. The incumbent will have a thorough understanding of the business strategy to deliver results for Regeneron's internal business units, taking into account all stakeholders including employees, hiring managers and leaders, the candidate marketplace, search firm partnerships and diversity/inclusion-affiliated organizations. Responsibilities: • Lead top of industry recruiting team that is customer focused, flexible, responsive, and achieves goals within established time frames and budgets. • Work directly with business stakeholders, including senior management, to acquire best in class industry talent. • Establish and develop effective working relationships with HR Business partners and senior business leaders to lead, and manage the recruitment process to meet short-term and long-term talent planning and gap strategies. • Provide thought leadership and subject matter expertise on talent in a competitive landscape to Talent Acquisition, HR and Leadership teams. • Lead with high integrity. Ensure recruitment methodologies and hiring practices are in compliance with government regulations and organizational policies and procedures to ensure appropriate and fair selection, assessment, pre-screening, and post-employment methodology. • Manage to established talent acquisition success criteria, through reports and metrics that demonstrate ROI including quantitative and qualitative success measures. • Demonstrate ability to think strategically, analytically and objectively. Effectively able to manage with data by translating data into actionable insights, strategies and action plans. • Be viewed as an expert and key partner to functional business and HR leaders on emerging staffing trends and workforce analytics. Gather stakeholder feedback to continuously drive quality and effectiveness improvements. • Carry ongoing workload of senior level open and confidential positions. • Manage searches in partnership with retained and contingent agency partners as needed. • Build systems and processes from the ground up, leveraging and managing in house, field based, and contract team members Requirements: • Requires BS/BA. MS preferred • Minimum of 10+ years of experience in Talent Acquisition or related field with biopharmaceuticals; experience/expertise with a working knowledge of drug development required • Prior leadership experience • Heavy recruiting project management experience • Exceptional business acumen; good judgment and intuition • Executive presence, a dynamic professional with the ability to inspire confidence in senior leadership and all stakeholders with whom she/he will interact • An outstanding communicator; Strong oral and written communication skills, in addition to strong presentation and listening skills • Strong interpersonal skills, intellectual capacity, emotional intelligence and an outstanding ability to build relationships both internally and externally; collaborative team player • Ability to successfully and genuinely influence without authority • A strong capacity to deal with ambiguity in a dynamic and entrepreneurial environment • Display energy, drive, passion, creativity and commitment • Knowledge of various CRM, ATS, and other recruitment technology platforms, legacy and new to market • Experience with skill and talent assessment tools and competency based interview models. #LI-LC1 This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
The Regeneron Genetics Center (RGC) is a wholly-owned subsidiary of the Company, whose goals are to apply large scale human genetics to identify new drug targets and to guide the development of therapeutics programs and precision medicine. Building upon Regeneron's strengths in mouse genetics and genetics-driven drug discovery and development, the RGC specializes in ultra-high-throughput exome sequencing, large scale informatics and data analysis encompassing genomics and electronic health records, and translating genetic discoveries into new biology and drug discovery opportunities. The RGC leverages multiple approaches including large population based studies, Mendelian genetics and family based studies, founder population genetics, and large-scale disease focused projects and has developed a network of over 50 collaborations with research organizations around the world. Including some of the largest sequencing studies in the world, such as the DiscovEHR study in collaboration with Geisinger Health System, and an initiative to sequence 500,000 participants with the UK Biobank, the RGC has built one of the largest human genetics databases, including sequence data from over several hundred thousand participants and rapidly growing. Our interests encompass a breadth of different areas across all therapeutic areas and the RGC is highly integrated into all facets of research and development at Regeneron. Program goals include target discovery, indication discovery, and patient-disease stratification. Objectives include advancing basic science around the world through public sharing of discoveries, providing clinically-valuable insights to physicians and providers of collaborating health-care systems, improving patient outcomes, and identifying novel targets for drug development. Summary: We are looking for a talented Genetic Epidemiologist with strong quantitative skills to join our Cardiovascular, Metabolic and Musculoskeletal Therapeutic Area Genetics team. The post holder will have key responsibilities in mining large human genetics datasets including 100,000s of genotyped and sequenced participants, in partnership with other RGC teams, to translate genetic findings into new therapeutic insights. The key goals of the post will be (a) to empower the translation of genetic association findings into new therapeutic targets, indications and precision medicine approaches that will enable Regeneron to deliver better medicines to the patients who need them in the fields of Cardiovascular, Metabolic and Musculoskeletal Medicine; (b) to support existing pre-clinical and clinical development programs within Regeneron in these Therapeutic Areas using human genetics approaches; (c) to form strong partnerships with the Analytical Genomics, Clinical Informatics, other RGC's teams to accomplish the goals of the Therapeutic Area Genetics team, RGC and Regeneron at large. Responsibilities: • Design and execute complex analyses across datasets to accomplish the translational goals of the Therapeutic Area Genetics team. • Work in close collaboration with other Therapeutic Area Genetics team members and form a strong partnership with Analytical Genomics, Clinical Informatics and other RGC teams to deliver on complex, top-quality scientific endeavours in these Therapeutic Areas. • Generate, summarise, and present results in internal and external meetings to a variety of audiences. Lead or contribute to the writing of scientific reports and publications. • Represent the Therapeutic Area Genetics team in cross-functional initiatives within RGC and Regeneron. • Collaborate with external industry and academic partners in scientific consortia. Requirements: • PhD in Genetic Epidemiology, Statistical Genetics (with an applied focus), Human Genetics or similar and strong quantitative and analytical skills. • 5+ years of experience and/or an outstanding level of achievement in the field of large-scale human genetics post PhD. • Expertise in the genome-wide and gene-centric analysis of large human genetics datasets for translational insights. The successful candidate will use (a) Mendelian randomization to elucidate causal mechanisms and evaluate whether pharmacological treatment of a target is likely to be effective and safe; (b) polygenic risk scores to enhance etiologic understanding and genetic prediction, (c) fine-mapping and other prioritization approaches to identify causal variants and genes underlying genetic association signals and (d) will routinely combine information across multiple traits, variants and data sources to generate new insights. An outstanding candidate will have contributed to the application of these methods to important biological problems in the field of Cardiovascular, Metabolic and Musculoskeletal Medicine. • Expertise with modern cluster and cloud computing environments and with statistical analysis software (R environment for statistical computing, STATA) and human genetics analysis tools (METAL, GCTA, PLINK or similar). • Interest in understanding the genetic basis of Cardiovascular, Metabolic and Musculoskeletal diseases and translating this knowledge into therapeutic insights. An outstanding candidate will have previously worked on cardiovascular, metabolic or musculoskeletal phenotypes. • Ability to work in a highly interactive environment with a diverse team of colleagues. Ability to provide mentorship and guidance to more junior colleagues to help them develop their full potential and build new skills and abilities. • Outstanding communication skills and an ability to summarize and present the results of human genetic studies to a variety of technical audiences, ranging from experts in statistical genetics, human genetics, biology, drug design and medicine. • A commitment to high-quality science and to the highest standards of research and work ethics and integrity. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Regeneron has grown very rapidly over the last 5 years. Not only have we grown over 500% --and now have close to 8000 employees -and commercially launched 4 new therapeutics, we have also been building the corporate functions and infrastructure that supports our Research, Development, IOPS and Commercial teams. The corporate functions have a foot print in the US, the UK and Dublin. Given the ongoing growth, key areas of HR support for this team include workforce planning, talent management, culture and employee engagement. Our corporate functions provide the right support to enable the outstanding innovation in research, the ability to develop over 20 products in the clinic, enable our production of high quality product for our patients and support our in-house and field commercial teams. The corporate (G&A) functions at REGN include areas such as Finance and Accounting, Legal, Corporate Communications, Strategic Sourcing and Procurement, Real Estate and Facilities, IT and HR. As Regeneron has grown and evolved, so has the HR function. We are on a several year journey and our on-going HR evolution is an investment in our own function -with a long term goal of HR having an even bigger impact on Regeneron's workforce & talent management practices and employee experience. We are investing in and implementing two foundational technologies (WorkDay and a centralized HR service center), creating an integrated Talent Management Center of Excellence and building our HR Business Partner capability to deliver more strategic HR support to our leaders. This HR role is a member of the G&A HR Business Partner team. This team supports 900+ employees and works collaboratively with each other and the HR Centers of Excellence (Talent Management, Total Rewards and HR Operations) to understand the strengths and the gaps across G&A and ensure HR can create programs and solutions that meet their business needs. HRBP's develop solutions to solve G&A business challenges in order to increase their ability to deliver on their everyday goal-supporting the teams that take Science to Medicine. You will be an advisor to executives, managers and employees on organizational and HR-related issues, including but not limited to workforce planning, talent acquisition and development, change management, organization design and effectiveness, employee engagement, employee relations, and performance management, to promote and maintain REGN's high-performance culture, the Regeneron Way. Key to this will also be your ability to quickly develop trusted relationships with people at all levels across G&A as well as within the HR team. You have to be comfortable with challenging the status quo in a growing team and be very comfortable with toggling back and forth between excellent tactical execution and making sure there is a sound and longer-term strategy behind all of our work and the solutions. The incumbent acts as a champion and a coach for the business, monitoring the effect of business decisions on people, and translating business needs to the HR COE's-and vice versa. Responsibilities: • Works with clients to help solve any people related issues, keeping in mind precedence and business needs. This includes partnering with internal HR experts (as needed) on employee relations, compensation, manager employee relations, leadership development, benefits, succession planning, employee development needs, etc. • Provides coaching to executives, managers and employees, with an emphasis on the helping the person understand what their options are for each situation and how demonstrating the Regeneron Way (our cultural values) can help drive their success. • Acts as the lead translator of business needs to the rest of the HR team to help shape company-wide HR systems and solutions. • A key focus will be on identification of key talent and developing a plan to either develop and or bring in those people to fill those talent gaps. Partners with Talent Acquisition and client groups to identify current and future talent needs. Clarifies the technical skills and behaviors that are critical for success. Participates in interviews for key positions (generally Assoc Dir and above), as well as the candidate debriefs. • Onboarding: Partners with hiring managers to support successful onboarding of new managers and leaders; may facilitate new leader ease-in sessions. • Learning & Organizational Development: Identifies needs (individual, team and department levels) within client areas and partners with L&OD to design solutions that will address business needs. Will be expected to be part of the design and delivery of the solution with L&OD. • Total Rewards: Partners with this team to define new roles, identify external comparable/market value of positions, implement annual pay for performance, market adjustments, and other reward and recognition programs, as well as developing, revising, and communicating career matrixes. • Employee Engagement: Uses Regeneron survey data results to help managers own and develop action plans that support their business and people needs. • HRBP team: Is an active contributor to an HRBP team that shares best practices and balance the needs of their own client group with the needs of the overall business. • Overall: Everything you do should directly support the capabilities of your client groups to meet their current and future business goals. #LI-LC1 Requirements: • Minimum of bachelor's degree in a scientific discipline or HR related discipline; advanced degree such as MBA, or Master's in Organization Development or Human Resources is preferred. • Minimum 10 years' experience in our industry: pharma/biopharma/biotech in an HR or management role. Experience supporting or working directly in a G&A organization is strongly preferred. • Must have experience working with senior management, technical leaders, and technical staff in the biotech/pharmaceutical sectors. Must know and understand the basics of the drug development business. • Must have expertise in talent acquisition and talent development within a technically driven organization. • Prior experience with Korn Ferry (previously Lominger) Leadership tools is a strongly preferred • Demonstrated track record of taking initiative, ability to get things done with a minimum of noise and the ability to prioritize the essential over the non-essential. • This role is both diagnostic and solution driven, so the ability to take a step back and do root cause analyses, and then using data to deliver pragmatic solutions are critical for success in this role. • Demonstrates a strong preference and ability for quantitative and qualitative data analysis, and be comfortable with a variety of technology, systems and data. This includes being agile with Microsoft Suite products, HRIS systems, and other people related systems (Korn Ferry/Lominger) • Must be learning agile and able to deal with ambiguity, and able to quickly translate complex people and data issues into clear and coherent solutions. • Must be able to actively negotiate and influence others, demonstrating courage and the ability to effectively push back on "that's the way we have always done it". Can identify the "third way" that can meet all party's needs. • Basic understanding of HR legal compliance requirements This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: The Exec Director, Late Clinical Development Biostatistics directs statistical support and provide statistical leadership for all areas of late-phase clinical development and has responsibility for strategic and operational activities. Promote development of key staff responsible for individual projects or areas. Implement and maintain policy for recruitment of high potential staff. Assisting VP, BDM, in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure. Responsible for project staffing and for appropriate resource allocation consistent with corporate priorities. Incumbent could serve as senior research expert, with demonstrated ability to be a leader within Global Clinical Operations (GCO) and within field for specific statistical methodology or application. Job Duties: • Determines in conjunction with department Vice President, department goals, and resource allocation. Ensure project teams have high quality statistical support for creation of clinical development plans (CDP), study design, and operational aspects. • Oversee process for statistical reporting. Review critical documents, such as SAP, Key Results, CSR, and integrated summaries. Ensure compliance with data submission guidelines. • Ensure appropriate statistical designs, data collection and analysis methodologies and processes to clearly and robustly address the objectives of clinical studies and programs. • Lead development and optimization of statistical processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices. • Work with senior management to ensure statistical representation in key project decisions and regulatory meetings. Serve as departmental representative on corporate-wide teams. • Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization across projects or areas. Effect long-range planning. • Sets strategy for how department will improve technical expertise and ensure technical direction and mentoring of staff. Develops staff on technical and personal development. Establishes a healthy culture in the department, including collaboration, quality mindset and motivation. • Oversees late stage clinical development. Manages other senior managers and is accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. • Identify business problems and establishes functional strategy, in collaboration with Head of BDM, and provides direction for team to craft solutions. • Thorough working knowledge of regulatory guidelines. Understanding of the drug discovery and development process, regionally and globally. • Alert staff to new or changing standards. Within area of control, harmonize policies with departmental guidelines / SOPs and with industry standards. Develop polices promoting application of corporate values in work practices. • Liaise with other company function leaders to influence, shape, and drive unified strategies related to integrated development programs and regulatory submissions. • Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group. Participates in Regeneron task forces and cross-functional operational excellence initiatives. • Actively participates in statistical conferences and proactively seeks ways to represent company externally and to sponsor internal staff to be active at external professional meetings. • Able to influence regulatory agencies, in both product-related forums and more generally in the industry and works with company to develop a regulatory strategy. • Sponsor/leader of cross-functional process initiatives. • Monitors performance of direct reports and proactively identifies and addresses gaps/issues to ensure performance goals/expectations are met. • Will have own individual objectives of a strategic nature at department and company levels. • Decisions will result in the long-term success of the function and will strongly influence the long-term success of the company. • Works closely with senior management. Establishes department in a leadership role in drug development and drives how the company approaches product development. • Extended member of DPR, PRC. Conducts all pre-PRC and pre-DPR reviews for BDM, within their area of responsibility. Ensures teams have appropriate plans, and reviews program and study strategy with teams, and mentors teams to improve their effectiveness in committee and senior management meetings. Requirements: Education: • Ph.D. in Statistics or related discipline with 13+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interaction with both FDA and EMEA, history of successful project and people management (6+ years), and expertise in multiple therapeutic areas Experience: • Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks. Works independently - self-directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required. • Demonstrated strong leadership, project management, teamwork, and interpersonal skills Excellent presentation skills • Responds well to questions, speaks clearly and persuasively in positive and negative situations. • Demonstrated written and oral communication skills • Listens and gets clarification • Adaptability- Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. • Strives to continuously build knowledge and skills; Shares expertise with others. • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance. • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. • Responds to management; takes responsibility for own actions; keeps commitments; completes tasks on time or notifies appropriate person with an alternate plan. • Experience and proven ability leading and managing major process and technology initiatives with utilization and impact across multiple functional groups • Broad knowledge and superior understanding of advanced statistical concepts and techniques • Outstanding ability and skills to effectively represent Biostatistics and Data Management in interaction with senior management or cross-functional committees • Thorough knowledge of pharmaceutical clinical development and life cycle management; ability to innovatively apply technical principles, theories and concepts to clinical drug development leading to regulatory approvals • Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice • Understanding of the drug development process, regionally and globally Strong administrative skills • SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery) This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. LMR, #LI-LR1
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: We are looking for a Sample Management Assistant for our Sample Management Group, who will be responsible for the proper handling, receipt, and storage of clinical study samples as per internal SOP's and GLP's. Responsibilities: • Receive clinical study sample shipments from clinical sites and Contract Research Organizations. • Accession clinical study samples and enter associated data in the LIMS database following applicable study protocols, supporting documentation, Regeneron SOP's, and GLP regulations. • Maintain clinical study sample inventories and process the movement of clinical study samples for request and disposal. • Prepare clinical study samples for shipment. • Maintain clear and accurate documentation. Educational Requirement: 0-2 years with a Bachelors Degree Experience: • Computer proficiency including spreadsheets and database experience is necessary as well as the ability to master new software programs; LIMS experience is a plus. • Ability to communicate effectively both verbally and in writing. • Prior experience handling clinical study samples is a plus. • Background in biology or chemistry preferred. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Provides administrative support for department and staff as required. Processes and proofreads various documents and correspondence, schedules calendar items, makes travel arrangements, processes forms, enters data, and maintains records. Responsibilities: • Supports a wide variety of word processing tasks which may be confidential in nature; Performs data entry; drafts, edits, revises, and prints letters, tables, reports, and other materials • Greets and directs visitors • Resolves routine administrative problems and answers inquiries concerning activities and operations of department/division • Facilitates and coordinates the scheduling of meetings and other department initiatives • Accepts, screens, and directs telephone calls • Prepares copies and facsimiles for staff members as needed • Schedules and coordinates meetings, appointments, conferences, interviews, and orders food for departmental activities as requested • Performs other duties related to maintaining department members' schedules • Orders, stocks, and distributes office supplies • Performs a range of staff and/or operational support activities, sometimes serving as a liaison with other departments on basic administrative matters • Associates Degree or Bachelor's Degree (preferred) • 3-5+ Years • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills • Strong knowledge of Microsoft Applications (MS Outlook, MS Word, MS PowerPoint, MS Excel, MS Visio) and Adobe Acrobat is required. Working knowledge with electronic document management systems is preferred. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Responsible for building inspections, general equipment inspections, general repairs and maintenance of the facility, lab and office relocations/renovations, furniture installation and repairs. Provides general assistance and support services as needed. May be asked to work overtime. Responsibilities: • Operation/driving of company vehicles • Provide general Facilities support as needed, including moves & relocations • Assists team members with Plumbing, HVAC controls, and other special projects. • Available 24/7 for emergency response. • Responsible for service requests. • Responsible for/ assist with Lab renovations, new equipment installations and electrical work. Requirements: Education • Associates Degree from an Accredited College or University and /or 3 to 5 years related experience and /or training. Experience • Associates Degree from an Accredited College or University and /or 3 to 5 years related experience and /or training. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. #LI-PD1
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
The Regeneron Genetics Center (RGC) is a wholly-owned subsidiary of the Company, whose goals are to apply large scale human genetics to identify new drug targets and to guide the development of therapeutics programs and precision medicine. Building upon Regeneron's strengths in mouse genetics and genetics-driven drug discovery and development, the RGC specializes in ultra-high-throughput exome sequencing, large scale informatics and data analysis encompassing genomics and electronic health records, and translating genetic discoveries into new biology and drug discovery opportunities. The RGC leverages multiple approaches including large population based studies, Mendelian genetics and family based studies, founder population genetics, and large-scale disease focused projects and has developed a network of over 50 collaborations with research organizations around the world. Including some of the largest sequencing studies in the world, such as the DiscovEHR study in collaboration with Geisinger Health System, and an initiative to sequence 500,000 participants with the UK Biobank, the RGC has built one of the largest human genetics databases, including sequence data from over several hundred thousand participants and rapidly growing. Our interests encompass a breadth of different areas across all therapeutic areas and the RGC is highly integrated into all facets of research and development at Regeneron. Program goals include target discovery, indication discovery, and patient-disease stratification. Objectives include advancing basic science around the world through public sharing of discoveries, providing clinically-valuable insights to physicians and providers of collaborating health-care systems, improving patient outcomes, and identifying novel targets for drug development. Summary The Genome Informatics and Data Engineering team is seeking a Senior Director of Application Development who will be responsible for leading the RGC Genome Informatics Web Application and Tool Development Efforts. Specifically, the candidate will be responsible for developing software tools and web applications that leverage the RGC infrastructure to provide expert and non-expert users alike the ability to mine insights from genomic and clinical data. The leader in this role will define the vision and strategy for application and tool development in support of RGC needs for mining genomic and clinical data coordinating with users and application development teams in other functions at the RGC and Regeneron to ensure that all RGC results are FAIR (findable, accessible, interoperable, and reusable). Key areas of development are tools that enable mining of variant data at the 1M sample scale across 100s of individual projects, and development of tools to support the extraction of phenotypes from EHR data and the integration and harmonization of clinical data from a broad array of heterogeneous sources in support of clinical informatics needs. Responsibilities • Set the strategy and vision in support of stakeholder needs for genome and clinical informatics application development at the RGC • Coordinate and collaborate with other development teams, IT and InfoSec, and external and internal collaborators to deliver world-class applications and tools. • Manage requirements gathering processes and development efforts to ensure the voice of the end-user is in every tool and application we develop • Provide documentation, FAQs, live trainings, and training videos to make it as easy as possible for users to understand how to use the tools and applications we develop • Manage contractor and external vendor relationships where needed to accelerate development timelines • Manage versioning and change control process to ensure smooth evolution of tools without loss of service or functionality • Provide end-users with clarity about the impact of changes and maintain the highest level of confidence in data quality and reproducibility. • Collaborate with teams across the RGC and Regeneron to ensure that all RGC data and tools are findable, accessible, interoperable, and reusable. Requirements This position requires a Ph.D. with 10+ years of experience in sequencing and/or genome informatics application development, plus 5 or more years of experience leading development efforts for widely-adopted commercial-grade genomics software tools. Additional requirements include: • Proven track record of developing, deploying, and supporting widely utilized genomics tools • Experience managing large collaborative development efforts, preferably in the context of large-scale NGS sequencing and analysis projects • Experience managing and coordinating with IT teams to maintain secure and compliant tools and applications • Experience with developing and deploying cloud-based tools (AWS preferred) • Experience with distributed data technologies and application development in the context of Spark and/or Hadoop-based back-ends • Experience developing scala-based tools in the Databricks platform a plus • Deep knowledge of NGS sequencing technologies • Excellent communication and presentation skills required • Experience in managing different workstreams and coordinating tasks with internal teams and outside consultants This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Accountable for building, leading, and managing a global Regulatory Submission Management department, working through managers who are responsible for sub-departments that project manage regulatory submissions; format and publish regulatory submission documents; publish an submit regulatory submissions; and manage Regulatory information through Regulatory system business-side project management, business analytics, Regulatory systems training, and archiving; and ensure Regulatory compliance. Responsibilities: • Accountable for overseeing and leading first line management of a Regulatory Submission Project Management team who are responsible for staff who: perform regulatory project management tasks for regulatory submissions such as developing and maintaining submission plans; developing and managing submission timelines; coordinating and tracking documents; and reporting on document and submission status. • Accountable for overseeing and leading first line management of a Regulatory Operations team who are responsible for staff who: ensure regulatory submission documents are properly formatted and published; ensure submissions are built per Agency specifications; provide guidance on submission build strategies to multidisciplinary teams. • Accountable for overseeing and leading first line management of a RIM team, which includes overseeing managers and staff who are responsible for project managing business systems projects; creating, maintaining, and training on pertinent Regulatory procedural documents; supporting business needs by liaising with internal stakeholders and the Regulatory Systems team, IT, and vendors to identify technical solutions; development and training on Regulatory submission document templates; training on Regulatory Information Management (RIM) systems and tools; archiving Regulatory records pertaining to multiple Regulatory Applications such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations all in accordance with applicable Regulatory Agency regulations, guidances, and/or specifications (eg, FDA, EMA, ICH, etc); marketing Regulatory systems and tools across the organization; and managing all Regulatory information pertaining to these applications. • Works closely with the Regulatory Systems team who are responsible for: supporting the company's ongoing regulatory initiatives by assisting in planning, implementing, integrating, and optimizing information systems needed for managing regulatory submissions worldwide. • Ensures there are sufficient resources to support planned submissions or other projects and communicates the need for additional resources to management as needed. Guides first line managers on effective management of their resources including vendors and contractors who support submission related activities. • Serves as the primary contact for RSM. Also serves as the primary contact with regulatory authorities for Regulatory technical matters. • Ensures the necessary SOPs, WPs, and standards for managing regulatory submissions worldwide are established and in accordance with all applicable Regulatory regulations, guidance, and specifications, as well as, company policies and procedures. • Leads and manages a highly successful, productive, and respected team by: identifying and hiring candidates who provide added value to our already robust and diverse talent portfolio; promoting a team environment that fosters both professional and personal growth; motivating, engaging, and empowering staff; coaching and mentoring staff through frequent and direct feedback; encouraging and supporting change; and maintaining a strategic focus that is aligned with the company's goals. • Provides support and backup to management as needed. Provides support and backup to the RSM team as an individual contributor during peak periods. • Leads and/or serves as a member of cross-functional committees and represents the interests of the RSM team Requirements: Education • Bachelor's Degree Experience • 15+ years This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: This management position in Regulatory Affairs involves the ability to lead and manage the regulatory affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition the position assists corporate senior management in understanding Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Job Duties: • Responsible for regulatory strategies for all development programs to ensure Regulatory Agency approval(s) within specified timelines of all activities in support of Regeneron's corporate development and marketing objectives. o Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate regulatory strategies in consultation with the Executive Director. o Review critical regulatory communications. Evaluate conformance with the regulatory requirements, clarity, and completeness. • Responsible for ensuring necessary state of compliance for all regulatory commitments/requirements: o Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc. • Supports department liaisons with their project specific communications, including Agency meetings. • Responsible for the completeness and accuracy of information provided in regulatory submissions. • Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation. • Permanent member of PRC and RCRC. • Responsible for the planning, preparation and submission of licensing applications. o Manages liaisons and/or provides direction to regulatory representatives to project teams who effect and communicate to multidisciplinary teams the content, format, style architecture and timing of a Biologics Licensing Application (BLA) and MAA. o Review application. Evaluate conformance with the regulatory requirements, clarity, and completeness. o Supervise Regulatory staff with respect to commercialization activities associated with new product registrations. • Responsible to senior management for timelines/budgets. • Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required Requirements: Education • Requires advanced degree in a science related discipline. MD, Ph.D, PharmD Experience • A minimum of 15 years of pharmaceutical industry or related experience, at least 5 of which should include regulatory experience. • Research laboratory, process development or manufacturing experience with biotechnology products highly desirable. • Must possess excellent written and verbal communication skills. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. New York, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Senior Director of Marketing, Field Force Integration, will contribute to the financial success of EYLEA® (aflibercept) Injection and will report to the Executive Director, Marketing. This person will have primary responsibility for the development of strategies and execution of tactical programs directly related to field execution that supports the growth of EYLEA across indications. Responsibilities: • Monitor market place via field feedback and field advisory boards, and collaborate with the brand team on promotional program course corrections • Align brand team on strategic intent and oversee execution of all POA activities including agenda management, planning and training • Coordinate with Sales Training on training programs, content and prioritization of topics, such as selling through step edits and payer restrictions • Develop Field Force tactical programs to support brand growth • Develop investment mix for speaker programs with execution goals • Act as primary point of contact for the field and coordinate field activities across marketing • Monitor sample utilization and make recommendations on how to optimize investment • Assess opportunities for and recommend incentive plans that are aligned with brand goals • Develop innovative approaches to work with distribution partners and organized customers to amplify brand messages and gain insights • Lead the development of key account plans based on local market payer dynamics • Build referral strategy and plans to ensure appropriate executions with the field • Support new hire training activities to improve onboarding process Requirements: • Demonstrated knowledge in Marketing or Market Access Marketing roles • Sales and Sales Management experience • Demonstrated results in executing differentiated programs in highly competitive therapeutic areas, including low cost generics • Buy and bill experience a plus • Experience in leading and developing long range brand plans and budgets • Experience working cross-functionally to develop account-based business plans • Experience in working closely with all sales force counterparts and gaining insights for sales force needs • Understands US reimbursement environment including governmental programs • Experience tracking and managing budgets with finance counterparts • Strong interpersonal & presentation skills required • Demonstrated ability to deal with all levels of the organization • Must be willing to travel 25-30% (including weekend travel as needed) Education and Experience: • Bachelor's Degree, MBA a plus • The ideal candidate must have a minimum 15 years of progressive experience in marketing/market access and sales in the life sciences. • Pharmaceutical Sales experience required • Launch experience This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: The HR Change Management Lead is a newly created position in the Regeneron HR function, recognizing the need to support a number of initiatives to be implemented over the next few years, including but not limited to a Workday implementation and the establishment of an HR Global Service Center. Coalesced under an "HR Evolution", these initiatives will drive critical changes to how HR delivers value to the business. Beyond near-term transformational support, this leader would create the foundational change management capabilities and manage change for future change initiatives within the HR function. The HR Change Management Lead reports to the Director, HR Communication & Strategy Optimization, and serves as an embeded resource to the project teams of the HR Evolution initiatives. Key responsibilities include: • Supporting project leaders and project teams to identify change impacts • Developing and implementing change management plans to address the needs for communications, stakeholder engagement, and training • Continuously assessing organizational readiness for the changes and refining the change management approach as necessary Responsibilities: • Collaborate with HRLT and project leaders to align leader and stakeholder expectations with the vision of HR Evolution initiatives. Help them understand and provide guidance on the identified change barriers, impacts, risk areas, and targeted mitigation strategies for the initiatives; • Consult and collaborate with HRBP leaders, Talent CoE and OD Consulting to develop change management strategies and plans. Ensure full leverage of inhouse expertise on change management. Communications • Develop communication materials • Drive all-HR level communication activities and maintain a Communications Plan for activities across initiatives and stakeholder groups • Support the HR Leaderhip Team and other HR leaders to communicate and engage their teams • Continuously assess communication effectiveness Stakeholder engagement and leadership alignment • Collaborate with HR leaders and project teams to identify and segment stakeholders • Consult HR leaders and project teams on stakeholder engagement plans and activities • Actively identify impacts and risks, and create communications and change management plans to effectively manage and mitigate risk • Track stakeholder engagement activites, assess effectiveness, and develop resistance mitigation plans, as needed • Establish and manage a Change Agent Network Training • Collaborate with project leaders and project teams to identify training needs and develop training strategies Team Management • Manage the Change Management Team Members, e.g. Training lead and Training team members, and other supporting resources in the completion of their responsibilities • Review and approve all change strategies and plans (i.e. communications, stakeholder engagement, change readiness, etc.) provided by implementation Requirements: Skills: • Ability to lead dynamically and energize multidiscipline work teams to learn and apply new skills/techniques to respond to business needs • Ability to quickly and continually learn cultural and operational nuances of different business units • Ability to develop creative and unconventional change management solutions that incorporates the organization mission, values, and culture • Ability to build and maintain a strong network and utilize their knowledge and experiences to influence solutions • Strong verbal and written communication skills, with an ability to relate organizational readiness concepts to business value • Strong analytical, problem-solving, and conceptual skills • Strong project management skills; experience in organizing, planning, and executing projects from vision through implementation, involving internal personnel, contractors, and vendors; ability to analyze project needs and determine resources needed to meet objectives • Strong teamwork and interpersonal skills; ability to communicate and persuade at all management levels and thrive in a cross-functional environment • Knowledge of the company's business practices and direction, as well as familiarity with the company's products and resources • Leadership presence and the ability to establish credibility necessary to influence at all organizational levels and give projects credibility Minimal Education Requirements: A Bachelor's degree in Business (or Management), Communications, Organizational Development, or related discipline, or equivalent work experience is required; a Master's degree (or equivalent) is highly desired Minimum Years of Experience: • 10-12 years of change management, communications and training experience, preferably in the Life Sciences industry. Experience in the HR field is a plus. • At least eight years of experience in project management and execution involving multiple major development projects • Five or more years of management experience in which one or more of the following occurred: o Demonstrated competency in strategic thinking and leadership with strong abilities in relationship management o Successfully developed and implemented change readiness and sustainability networks using organizational readiness best practices o Successfully developed resistance management plans that helped mitigate resistance at both leadership, management, and staff levels o Established a track record of managing staff through various life-cycle phases o Demonstrated leadership of multidiscipline, high-performance work teams/groups o Demonstrated high competency in project management and the execution of multiple large projects, including managing resources across multiple projects to meet goals and driving forward decisions and deliverables o Developed efficient and effective solutions to diverse and complex business problems #LI-LC1 This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Rensselaer, NY 12144, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Develop and execute worldwide CMC regulatory strategies for investigational and commercial products. Also perform RA-CMC compliance activities to support IOPS organization. Responsibilities: • Create and execute regulatory strategies for worldwide investigational and registrational submissions, e.g., IND, IMPD, BLA, MAA, NDS, Japaneese NDA, etc. • Assist with planning, scientific writing and performing critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements in eCTD format to ensure a high quality regulatory submission and approval. • Assist in the preparation of eCTD sections for post approval submissions like CBE 0, CBE 30, PAS for the U.S. and Types I and II Variations for Europe. • Be a CMC liaison with Health Authorities worldwide. • Be part of the project teams and provide regulatory CMC guidances on critical issues. • Manage timelines in cooperation with project management, IOPS/Tarrytown SMEs and Tarrytown Regulatory Operations (RegOps) to ensure on-time regulatory submissions with highest quality. • Assist in review of IOPS change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and ensure that manufacturing and analytical changes are reported to the competent authorities in accordance with the current regulatory requirements. • Perform regulatory release for investigational products. • Evaluate manufacturing deviations and propose proper regulatory implications. • Assist in tracking regulatory commitments in INDs, IMPDs, CTAs and BLAs/MAAs. • Participate in planning, organizing and managing the CMC component of meetings with the FDA and other regulatory bodies. Requirements: Requires a BS or MS degree in a scientific displine with a minimum of 8 years of experience in Biotech and/or Pharmaceutical CMC area. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: This position reports to the Global Regulatory Liaison, Director or above, and provides support to the GRL in all aspects of regulatory affairs related to the development of novel gene therapy products including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. The main focus is expected to be on gene therapy and related technologies but could also extend to other therapeutic modalities. Job Duties: • Contribute to the development of regulatory strategies for gene therapy products. • Review and approve technical documentation including validation protocols, manufacturing and labeling information, technology transfer protocols, and technical reports. • Assist in the preparation, compilation, and organization of regulatory submissions (e.g. INDs, BLAs, MAAs, annual reports, IND amendments, BLA supplements, etc.) and ensure timely submission of above in accordance with title 21 CFR and FDA, EU and ICH guidelines. • Critically review regulatory documents in addition to performing quality control review for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs • Manage regulatory communications, including drafting of letters based on templates • Participate in cross-functional team meetings, as required, in collaboration with, and to assist, the GRL • Conduct research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy Requirements: Education • Ph.D. in in molecular biology, chemistry, biochemistry, or related scientific field. • M.S. may be considered on a case-by-case basis Experience and Skills • 2 years of pharmaceutical industry experience - relevant academic experience may be considered on a case-by-case basis • Strong oral and written communication skills • Ability to plan and organize effectively • Attention to detail and follow through This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: The Head of Regulatory Affairs International will provide leadership for regulatory filings in international markets outside of the US and EU (most of world markets). The candidate will contribute to and/or lead CTA and MAA submissions activities in these markets. Responsibilities: This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. Responsibilities include • Planning, managing and executing global CTA, IMPD and MAA submissions • Internal communication with key stakeholders across development and CMC • External communication with international Health Authorities, partner companies and their affiliates, and CROs. • Monitoring newly published international guidance documents Requirements: • Managing and mentoring direct reports and/or junior staff members. • 8-10 years of industry experience required • Education: Ph.D., Pharm D. or MD This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc. Tarrytown, NY, USA
Sep 20, 2019
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Leads combination product regulatory activities, including device development activities, protocol reviews, overseeing/managing Health Authority (HA) correspondence and submissions. This role includes overseeing various outside contractors, supporting project teams and development partners and leading Health Authority activities. Responsibilities: • Provide regulatory interpretation, position and strategy for combination products and devices' requirements • Support device development activities from a regulatory standpoint during early phase, development, submissions and post market requirements • Support development of design control documentation and quality systems for combination products • Support combination products regulatory submissions, including obtaining HA feedback and submitting IND, CTA, BLA applications and MAA filings. Requirements: Requires Bachelors in Science, Applied Science, Engineering, Industrial Design, or similar and 10+ years' experience, Master's Degree with 8+ or PhD with 3+ years working with medical, commercial or industrial products from pharmaceutical, regulatory, design, testing, validation, ergonomics and human factor perspective. Ideal candidate will have a combination of regulatory, pharmaceutical, device design, testing, human factors and usability expertise in regulated environment. • Expertise with implementing device regulations is necessary • Strong Technical writing and oral communication skills • Experience with Health Authorities, V&V protocols and test reports • Previous experience with device regulatory requirements and development processes for combination products • Experience writing technical documents like test reports, technical memos, input requirements documents, human factors protocols, etc. • Experience preparing information for 51Ok, IDE, IP and PMA submissions is a plus • Human Factors and Pharmaceutical experience • Regulatory submission experience • Understanding of global regulatory requirements for device and combination products This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.