Director of Regulatory Affairs

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