• Director, Scientific Expert CMC

    Boehringer Ingelheim (Athens, GA)
    …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
    Boehringer Ingelheim (12/12/25)
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  • Senior Manager, RA CMC

    AbbVie (North Chicago, IL)
    …works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and ... teams to negotiate, influence, and provide strategic advice. + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions,… more
    AbbVie (12/13/25)
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  • Executive Director, CMC Program Management…

    Regeneron Pharmaceuticals (Troy, NY)
    …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... conjugates, peptides). Responsible for end-to-end operational coordination-linking Manufacturing, R&D, CMC , clinical, regulatory -to enable accelerated development and… more
    Regeneron Pharmaceuticals (11/11/25)
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  • Executive Director, CMC Program Management…

    Regeneron Pharmaceuticals (Troy, NY)
    …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... execution from early development through commercialization, ensuring timely supply, regulatory readiness, and strategic coordination across all technical and… more
    Regeneron Pharmaceuticals (11/11/25)
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  • Global Manufacturing Sciences CMC Lead

    Takeda Pharmaceuticals (Lexington, MA)
    …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... lifecycle management and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings, market expansions,… more
    Takeda Pharmaceuticals (12/04/25)
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  • CMC Dossier Leader

    Sanofi Group (Waltham, MA)
    …organization has critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company's ... approval of CMC dossiers + Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from… more
    Sanofi Group (12/04/25)
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  • Director/Senior Director, CMC , Drug…

    Lilly (Indianapolis, IN)
    …(CROs, CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product ... for people around the world. **Job Summary** The Director/Senior Director, CMC , Drug Product Development will lead formulation development activities across multiple… more
    Lilly (12/09/25)
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  • Sr. Statistician - Chemistry, Manufacturing,…

    Merck (West Point, PA)
    …+ Prepare clear statistical content for Chemistry, Manufacturing, and Controls ( CMC ) documentation; assist with regulatory queries using sound statistical ... **Job Description** **Sr. Statistician - Chemistry, Manufacturing, and Controls ( CMC )** R3 Under the general supervision of a senior staff member in Center for… more
    Merck (12/18/25)
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  • Exec Director, Regulatory…

    Gilead Sciences, Inc. (Washington, DC)
    …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… more
    Gilead Sciences, Inc. (12/03/25)
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  • Associate Director, Regulatory Affairs…

    Sumitomo Pharma (Lincoln, NE)
    …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … more
    Sumitomo Pharma (10/11/25)
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