Regulatory Affairs Specialist (Biotech)

  • Jobot
  • Gaithersburg, MD, USA
  • Aug 01, 2020
Full time Government

Job Description

Regulatory Affairs Specialist (Biotech)

This Jobot Job is hosted by: Emmet Nitto
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $80,000 - $105,000

A bit about us:

Based in Gaithersburg, MD we are a clinical stage biopharmaceutical company focused on developing liver disease and immune modulating therapies. Our diverse pipeline includes next generation peptide therapeutics, chronic Hepatitis B, and immunostimulants for the treatment of cancer and intra-nasal vaccines. We are looking for a Regulatory Affairs Specialist (Biotech) to join our growing team!

Why join us?
  • Competitive Salary!
  • Great Benefits Package!
  • The Opportunity to Join an Amazing Team!


Job Details
  • Bachelor's Degree
  • 3-5 years of experience
  • Experience submitting through FDA's ESG
  • Good understanding of applicable FDA and ICH guidelines related to regulatory submissions
  • Good understanding of eCTD publishing systems, EDMS technology and authoring tools and templates.
  • Clear understanding of regulatory submission content and format requirements
  • Experienced in lifecycle management eCTD submissions including but not limited to, IND Safety, and IND Investigator submissions
  • Skilled in ISI Toolbox, Adobe Acrobat DC, Lorenz Validation
  • 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


Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.