Our client, a world leading Pharmaceutical Company in Thousand Oaks, CA is currently looking for a CMC Regulatory Affairs Associate / Remote-Workto join their expanding team.
Job Title: CMC Regulatory Affairs Associate / Remote-Work
Duration: 5 months contract, extendable up to 36 months
Location: Thousand Oaks, CA
Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
You may participate in the company group medical insurance plan
Ideal candidate will be working remote until the site reopens.
Manager is open to non local candidates but must work PST hours
Bachelors Degree Minimum
5+ years of RA experience in Manufacturing, Testing, Change Control, Pharma or Biotech. Must understand the processes.
The CMC Site team is responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative.
The RA CMC Senior Associate will interface with global and regional CMC regulatory leads, site teams and supply chain for specific strategies or activities that impact a product or multiple products. The RA CMC Sr Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.
Day to Day Responsibilities:
Assessment of manufacturing, testing, and supplier change controls for regulatory reportability
Provide assessment of deviations for impact to product filings
Top 3 Must Have Skill Sets:
Biologics manufacturing or regulatory affairs CMC experience
Ability to prioritize, multi-task, and understand complex manufacturing and/or testing changes
Self-starter. Appropriate training materials will be provided, but onboarding and work will be remote with no micromanaging from supervisor.
Employee Value Proposition:
Exposure to different departments. Wide variety of processes, products & opportunity.