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Director of Cmc Regulatory jobs

Viewing 1 - 10 of 49 jobs

  • Regulatory Affairs Associate - CMC

    Scientific Search - Edgewater, NJ

    CMC: Near Edgewater, NJ area Position Overview Regulatory Affairs Specialist – CMC: Ensures regulatory ... of CMC changes to current marketing applications. The Regulatory Affairs Associate DirectorCMC is also responsible...

    1 day ago from ZipRecruiter

  • Director of Regulatory Affairs

    Biotest Pharmaceuticals - Boca Raton, FL

    regulations and the business implications.The Director-Regulatory Affairs supports and organizes the preparation of ... Minimum of 7 years current/prior experience in Biologics Regulatory Affairs function with a background in CMC, FDA and c...

    14 days ago from Biospace

  • Director Product Quality

    Fulltimegigs - Lexington, MA

    Method transfers /validation, data verification of regulatory filings) • Specification establishment and management 30% ... includes ensuring appropriate quality review of regulatory submissions (i.e. filings, annual reports, responses to...

    12 days ago from FullTimeGigs

  • Director of Analytical Development

    Sterling Life Sciences - Philadelphia, PA

    company, is currently seeking a driven and ambitious Director of Analytical Development to join their team. This ... documents pertinent to analytical development and QC for regulatory submissions 10) Maintain oversight of precursor...

    6 days ago from ZipRecruiter

  • Sr. Director/Director, Regulatory Affairs, CMC

    Alnylam Pharmaceuticals - Cambridge, MA

    Director/Director, Regulatory Affairs, CMC will be responsible for developing and implementing CMC regulatory strategies ... of 5 years in CMC Regulatory Affairs. Sound understanding of chemistry and QA-related issues. Detail oriented;...

    15 days ago from Alnylam Pharmaceuticals

  • Regulatory CMC Lead- IMBU- GIBU- NSBU

    Shire Pharmaceutical - Lexington, MA

    Primary Role Under the direction of the Senior Director of Regulatory Affairs, direct and manage Regulatory Affairs ... • Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory...

    30+ days ago from Shire Pharmaceutical

  • Reg-CMC Lead- RDBU (Director)

    Shire Pharmaceutical - Lexington, MA

    of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global CMC ... regulatory colleagues in development of global CMC regulatory strategies. Determine applicable registration...

    30+ days ago from Shire Pharmaceutical

  • Reg CMC Lead- GI

    Shire Pharmaceutical - Lexington, MA

    Primary Role Under the direction of the Senior Director of Regulatory Affairs, direct and manage Regulatory Affairs ... • Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory...

    30+ days ago from Shire Pharmaceutical

  • Director of Regulatory Affairs

    Sterling-hoffman Executive Search - Chicago, IL

    2) RAC certification an asset 3) Minimum 15+ years of regulatory affairs with extensive senior management ... generics 5) Extensive CMC submissions and eCTD submissions (electronic) mandatory (module 4 and 5 of ANDA/NDA...

    7 days ago from Sterling-Hoffman Executive Search

  • Senior Director, Regulatory Affairs

    Techusa - Frederick, MD

    Senior Director, Regulatory Affairs Washington D.C. Metro Area Tech USA is currently seeking a Senior Director of ... Associate Director/Director of Regulatory Operations in the preparation and assembly of submissions to regulatory...

    30+ days ago from TechUSA