• Director , Regulatory Site…

    Takeda Pharmaceuticals (Boston, MA)
    …of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant ... based on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and… more
    Takeda Pharmaceuticals (06/04/25)
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  • Senior Advisor/ Director Global…

    Lilly (Indianapolis, IN)
    …all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in...with CMC team members. + Engage in site -specific regulatory activities to ensure maintaining registered… more
    Lilly (06/05/25)
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  • Senior Director , Regulatory Affairs…

    Bristol Myers Squibb (Indianapolis, IN)
    …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position ... to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
    Bristol Myers Squibb (07/29/25)
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  • Director , CMC Product Development

    AbbVie (North Chicago, IL)
    … regulatory queries, and participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. timelines, ... high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of… more
    AbbVie (05/07/25)
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  • Associate Principal Scientist (Associate…

    Merck (Upper Gwynedd, PA)
    …Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products ... - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in...regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of… more
    Merck (07/19/25)
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  • Director , Sterile Product Development

    Merck (Rahway, NJ)
    …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Pharmaceutical Development, Pharmaceutical Microbiology, Pharmaceutical Sciences, Pharmacokinetics, Product Development, Regulatory CMC , Software Development {+ 3 more}… more
    Merck (07/24/25)
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  • Sr. Director - Process Translation…

    Lilly (Lebanon, IN)
    …trial medicines, while also reducing costs and environmental impact. The Senior Director , Process Translation and Execution is directly responsible for managing the ... site Process Translation and Execution function and ensuring it...of the art Clinical Trial Manufacturing plant. The Senior Director Process Translation and Execution provides administrative and technical… more
    Lilly (07/31/25)
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  • Director , Viral Vector Process Design

    Gilead Sciences, Inc. (Santa Monica, CA)
    …development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly ... collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners. In addition,… more
    Gilead Sciences, Inc. (06/08/25)
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  • Director , Product Quality Lead

    Gilead Sciences, Inc. (Foster City, CA)
    …patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality ... the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC , and the wider PDM Quality organization. The successful candidate must have… more
    Gilead Sciences, Inc. (07/29/25)
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  • Director , Engineering - Drug Product…

    Merck (West Point, PA)
    …(DoE) and statistical data analysis. + Experience in authoring and reviewing CMC regulatory documentation. + Financial acumen with experience in resource ... **Job Description** **Job Description: Director , Center of Excellence for Sterile Drug Product...+ Experience with implementing platforms and standard work in CMC commercialization, technical operations or manufacturing + Experience with… more
    Merck (07/17/25)
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