• Director Regulatory CMC

    Actalent (Boston, MA)
    Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a ... Director /Sr. Director of Regulatory CMC based in Boston with a hybrid option. This role involves providing Regulatory CMC leadership for a dynamic… more
    Actalent (09/09/25)
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  • Director , Regulatory Site…

    Takeda Pharmaceuticals (Boston, MA)
    …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management ... requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market… more
    Takeda Pharmaceuticals (08/28/25)
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  • Associate Director , Global…

    Takeda Pharmaceuticals (Boston, MA)
    …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. You… more
    Takeda Pharmaceuticals (07/08/25)
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  • Director , Regulatory Affairs

    Sumitomo Pharma (Boston, MA)
    …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
    Sumitomo Pharma (09/09/25)
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  • Executive Director , Regulatory…

    Orchard Therapeutics (Boston, MA)
    …closely collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively...technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested. .… more
    Orchard Therapeutics (09/09/25)
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  • Senior Director , Global Product Quality,…

    Bristol Myers Squibb (Devens, MA)
    …s general support and leadership within the Global Product Quality organization . The Sr. Director a uthor s designated sections of regulatory filing s , review ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Cell Therapy Global Product Quality Lead ( Sr....queries, as needed . + R epresent Quality in CMC meetings with global regulatory agencies and… more
    Bristol Myers Squibb (09/05/25)
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  • Director Global Regulatory Affairs

    Fresenius Medical Center (Waltham, MA)
    …considerations into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory trends, ... AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a… more
    Fresenius Medical Center (06/14/25)
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  • Director , Pharmaceutical Sciences Program…

    Takeda Pharmaceuticals (Boston, MA)
    …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… more
    Takeda Pharmaceuticals (06/27/25)
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  • Associate Director , Small Molecule…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
    Otsuka America Pharmaceutical Inc. (08/27/25)
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  • Head, Analytical Controls (Sr. Director )

    Takeda Pharmaceuticals (Lexington, MA)
    …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
    Takeda Pharmaceuticals (09/04/25)
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