• BioSpace (Boston, MA)
    …provider's needs, enhance patient experience, and remain compliant with company and regulatory standards. As the Associate Director , Patient Services Operations, ... to deliver your best. Join Takeda as the Associate Director , Patient Services Operations out of our Cambridge, MA...Contracts and Pricing, Legal, Compliance, Training, Medical and Scientific Affairs and Regulatory , along with relevant external… more
    Upward (07/01/25)
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  • Akebia Therapeutics (Cambridge, MA)
    …functional groups such as monitoring, data management, biostatistics, medical writing, safety, regulatory affairs and QA. The individual will also be responsible ... we are all in, are you? Job Summary: Reporting to the Sr. Director , Clinical Operations, the successful candidate will provide operational leadership and expertise… more
    Upward (07/18/25)
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  • Takeda Pharmaceutical Company Limited (Lexington, MA)
    …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). Minimum of 5… more
    Upward (07/07/25)
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  • Associate Director , Global

    Sanofi Group (Cambridge, MA)
    **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy… more
    Sanofi Group (06/27/25)
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  • Director , Global Regulatory

    Sanofi Group (Cambridge, MA)
    **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
    Sanofi Group (06/27/25)
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  • Director , Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    …what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How… more
    Takeda Pharmaceuticals (07/02/25)
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  • Associate Director , Global

    Takeda Pharmaceuticals (Boston, MA)
    …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion ... prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
    Takeda Pharmaceuticals (07/20/25)
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  • Director , Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
    Takeda Pharmaceuticals (07/08/25)
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  • Associate Director , Global

    Sanofi Group (Cambridge, MA)
    **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... thought was possible. Ready to get started?​ **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more
    Sanofi Group (07/18/25)
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  • Senior Director Global

    Takeda Pharmaceuticals (Boston, MA)
    …possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of… more
    Takeda Pharmaceuticals (07/18/25)
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  • Associate Director , Global

    Takeda Pharmaceuticals (Boston, MA)
    …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
    Takeda Pharmaceuticals (05/13/25)
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  • Director Global Regulatory

    Fresenius Medical Center (Waltham, MA)
    …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… more
    Fresenius Medical Center (06/14/25)
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  • Director Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
    Takeda Pharmaceuticals (07/18/25)
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  • Senior Director , Global

    Takeda Pharmaceuticals (Lexington, MA)
    …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals… more
    Takeda Pharmaceuticals (04/30/25)
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  • Associate Director , Regulatory

    Rhythm Pharmaceuticals (Boston, MA)
    …commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
    Rhythm Pharmaceuticals (06/18/25)
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  • Director , Regulatory Advertising…

    Sumitomo Pharma (Boston, MA)
    …, Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...function as the Regulatory reviewer for assigned products. This position is responsible… more
    Sumitomo Pharma (07/08/25)
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  • Medical Director , Global Medical…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
    Otsuka America Pharmaceutical Inc. (07/16/25)
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  • Executive Director , Regulatory

    Regeneron Pharmaceuticals (Cambridge, MA)
    …might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC) for investigational and ... this key leadership role, you will build and oversee Global Regulatory Science and Regulatory ...position you will build and lead a cell medicine regulatory affairs team and provide regulatory more
    Regeneron Pharmaceuticals (07/11/25)
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  • Executive Director , CNS Strategy,…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    **Position Summary** : Reporting to the Vice President, Global Medical Affairs , the Executive Director , CNS Strategy, Global Medical Affairs is a ... but are not limited to the following: + Represents Global Medical Affairs on extended brand leadership...Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable for resourcing… more
    Otsuka America Pharmaceutical Inc. (07/11/25)
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  • Associate Director , Scientific…

    Takeda Pharmaceuticals (Boston, MA)
    …grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications ... in coordination with relevant cross-functional teams (including members of medical affairs , clinical development, and outcomes research; global , regional, or… more
    Takeda Pharmaceuticals (07/02/25)
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