Director of Regulatory Affairs
Meet Life Sciences, South San Francisco, CA, United States
Director Regulatory CMC Job Details
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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 xywuqvp 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
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.
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 xywuqvp 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