• Global Regulatory Affairs…

    Sanofi Group (Framingham, MA)
    **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA Waltham, MA **About the Job** Are you ready to shape the future of ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a… more
    Sanofi Group (09/19/25)
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  • GRA Device Lead (Director)

    Sanofi Group (Cambridge, MA)
    …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
    Sanofi Group (07/15/25)
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  • Global Head, BioAnalytics, CMC…

    Sanofi Group (Framingham, MA)
    …non-viral LNPs), with teams in France, Germany and the USA. Reporting to the head of Global CMC Development, this highly visible role has the potential to make a ... **Job Title:** Global Head, BioAnalytics, CMC Development **Location**...and with other Sanofi functions (eg, Research, Quality Assurance, Regulatory Affairs , Manufacturing & Supply, Business Development).… more
    Sanofi Group (09/20/25)
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  • Senior Manager of Statistics- CMC

    Takeda Pharmaceuticals (Cambridge, MA)
    …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
    Takeda Pharmaceuticals (09/03/25)
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  • Director, Regulatory Affairs

    Sumitomo Pharma (Boston, MA)
    …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
    Sumitomo Pharma (09/09/25)
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  • Senior Manager, Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …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...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
    Otsuka America Pharmaceutical Inc. (08/22/25)
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  • Senior Principal Regulatory Affairs…

    Bausch + Lomb (Boston, MA)
    …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a… more
    Bausch + Lomb (09/06/25)
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  • Senior Principal Regulatory Affairs…

    Bausch + Lomb (Boston, MA)
    …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer… more
    Bausch + Lomb (09/06/25)
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  • Executive Director, Regulatory Science

    Orchard Therapeutics (Boston, MA)
    …their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a consistent global approach is used for the development and ... discipline preferred. . At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning...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 Manager, Regional Regulatory Lead…

    CSL Behring (Waltham, MA)
    …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ... SMT and related delivery teams. May lead discussion at Global Regulatory Forum (GRF) or with senior...maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities… more
    CSL Behring (10/01/25)
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