Director of Regulatory Affairs Job at Meet Life Sciences, South San Francisco, CA

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  • Meet Life Sciences
  • South San Francisco, CA

Job Description

Director Regulatory CMC Job Details

  • Author or direct the preparation, authoring, and technical review of CMC sections for global filings:
  • ND/IMPD: Investigational applications for early-phase trials
  • NDA/BLA/MAA: Marketing applications for US, EU, and other major markets
  • Manage the lifecycle of the Common Technical Document (CTD) specifically focusing on Module 3 (Quality) and Module 2.3 (Quality Overall Summary)

Position Requirements

  • B.S./M.S. in a scientific discipline (Chemistry, Biology, or Pharmacy); A Ph.D. or PharmD is highly preferred
  • 10+ years of experience in the biopharmaceutical industry, with at least 7 years focused specifically on CMC Regulatory Affairs
  • Successful track record of contributing to least one major marketing application (NDA or BLA) from initial drafting through approval
  • Strong understanding of GMP (Good Manufacturing Practices) and ICH guidelines and deep knowledge of small molecule and mAbs modalities
  • Must be willing to work onsite at least four days per week

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