• Manager , Regulatory CMC…

    Kelly Services (Winston Salem, NC)
    **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to...method development, manufacturing, or process development. + Experience with global regulatory filings and knowledge of FDA,… more
    Kelly Services (07/30/25)
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  • Senior Manager , Regulatory Affairs…

    AbbVie (Waltham, MA)
    …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand...regulatory agencies. + Responds to global regulatory information requests. + Develops strategies for CMC… more
    AbbVie (07/25/25)
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  • Associate Director, Regulatory CMC…

    BeOne Medicines (San Mateo, CA)
    …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
    BeOne Medicines (06/25/25)
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  • Regulatory Affairs Assoc II CMC…

    Gilead Sciences, Inc. (Foster City, CA)
    …knowledge, with manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends. **Basic ... exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory...with strategic planning, problem solving, and working within a global matrix team environment. + Good understanding of the… more
    Gilead Sciences, Inc. (07/29/25)
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  • Manager , CMC Development…

    Sanofi Group (Morristown, NJ)
    …with the M&S Hubs supporting the technical writing function. + Collaborate closely with Global Regulatory Affairs (GRA) CMC to align on dossier strategies. ... **Job Title:** Manager , CMC Development and Dossiers **Location**...content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and… more
    Sanofi Group (07/25/25)
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  • AI & Data Manager - Life Sciences R&D…

    Deloitte (Stamford, CT)
    …(ie: Veeva Vault RIM, Lorenz docuBridge, MasterControl, or similar); and + Involvement with CMC modules (Module 3 of CTD/eCTD) for global submissions, as well as ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA,… more
    Deloitte (07/17/25)
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  • Senior Manager , Global…

    Otsuka America Pharmaceutical Inc. (Bismarck, ND)
    …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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  • Sr. Principal Project Manager - API…

    Lilly (Lebanon, IN)
    …implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
    Lilly (05/07/25)
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  • Senior Regulatory Affairs Specialist

    Grifols Shared Services North America, Inc (Clayton, NC)
    …other duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability ... member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for...the team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is… more
    Grifols Shared Services North America, Inc (05/14/25)
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  • Associate Director, Regulatory Affairs

    Bausch Health (Bridgewater, NJ)
    …+ Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory ... Join our global diversified pharmaceutical company enriching lives through our...drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/… more
    Bausch Health (07/01/25)
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