• Associate Director, Global

    Takeda Pharmaceuticals (Boston, MA)
    …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Lead , GI & Inflammation where you will ... define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
    Takeda Pharmaceuticals (09/21/24)
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  • Director, Global Regulatory

    AbbVie (Waltham, MA)
    …Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
    AbbVie (09/20/24)
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  • Global Regulatory Lead

    Sanofi Group (Cambridge, MA)
    **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory ... you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable… more
    Sanofi Group (10/12/24)
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  • Director - Global Regulatory

    Novo Nordisk (Lexington, MA)
    regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
    Novo Nordisk (09/13/24)
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  • Associate Director, Global

    Takeda Pharmaceuticals (Boston, MA)
    …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
    Takeda Pharmaceuticals (10/24/24)
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  • Director, Global Regulatory Affairs…

    Merck (Boston, MA)
    …and obtain shortest time to approval by regulatory agencies. + Functions as global regulatory lead assigned to programs where the compound is ... approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory more
    Merck (10/31/24)
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  • Director, Global Labeling Strategy…

    Takeda Pharmaceuticals (Cambridge, MA)
    …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... with immunologic, hematologic, and other complex diseases. The Director, Global Labeling Strategy Lead is a key...Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling,… more
    Takeda Pharmaceuticals (11/09/24)
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  • Associate Director, Global Labeling…

    Takeda Pharmaceuticals (Boston, MA)
    …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory more
    Takeda Pharmaceuticals (10/16/24)
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  • Regulatory Strategist

    Sanofi Group (Waltham, MA)
    …disease. The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL). We are an innovative global ... the delivery of business objectives. In this role you will: + Enable the Global Regulatory Lead (GRL) to provide regulatory position to support business… more
    Sanofi Group (11/08/24)
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  • Regulatory Strategist

    Sanofi Group (Cambridge, MA)
    …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... **Primary Location** : Cambridge, MA **About the Job** Our Global Regulatory Team is involved in developing...request of GRL + May serve as a regional/local regulatory lead and point of contact with… more
    Sanofi Group (11/07/24)
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  • Regulatory Strategist

    Sanofi Group (Cambridge, MA)
    …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... expertise to contribute to the definition of the global regulatory strategy, to enable and drive...management of products. + May serve as a regional/local regulatory lead and point of contact with… more
    Sanofi Group (10/03/24)
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  • Senior Principal Scientist (Senior Director)…

    Merck (Boston, MA)
    …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... and the delivery of targeted product labeling + Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single… more
    Merck (10/31/24)
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  • Associate Director, Global

    Takeda Pharmaceuticals (Boston, MA)
    …and PMDA, (Japan) Scientific Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy and the KO of ... must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project… more
    Takeda Pharmaceuticals (10/12/24)
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  • Associate Director, Global

    Takeda Pharmaceuticals (Boston, MA)
    Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of ... opportunities. + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
    Takeda Pharmaceuticals (09/07/24)
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  • Senior Manager, Global Quality Compliance:…

    Olympus Corporation of the Americas (Westborough, MA)
    …agencies regarding compliance issues. Leads and manages the development of all global regulatory communication processes to include responses external audits, ... Duties** + Authors, leads and manages the development of global regulatory communication processes to include responses...+ Experience as both audit front and back room lead and strategist. + Technical subject matter expert in… more
    Olympus Corporation of the Americas (10/23/24)
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  • Director, Global Regulatory Affairs…

    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 ... Director GRA CMC where you will independently develop and lead the execution of regulatory CMC investigational,...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
    Takeda Pharmaceuticals (11/10/24)
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  • Head, Global Regulatory Operations

    Takeda Pharmaceuticals (Boston, MA)
    … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the...lead complex outsourcing projects. + Deep understanding of regulatory information management + Savvy and effective negotiation skills… more
    Takeda Pharmaceuticals (10/24/24)
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  • Manager, Regulatory Lead

    Takeda Pharmaceuticals (Boston, MA)
    …Liaises with the US FDA on submissions within their responsibilities. + Serves as the lead interface between PDT global regulatory affairs, global ... with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for... for one or more projects and coordinates the Global Regulatory Team (GRT) meetings composed of… more
    Takeda Pharmaceuticals (11/08/24)
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  • Senior Director and Regulatory Platform…

    Takeda Pharmaceuticals (Boston, MA)
    regulatory guidance on Human Factors to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy, briefing book authoring and meetings with … more
    Takeda Pharmaceuticals (09/24/24)
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  • Head of US Commercial and Global Brand…

    Sanofi Group (Cambridge, MA)
    **Job Title:** Head of US Commercial & Global Brand Lead , Alphamedix **Location** : Cambridge, MA **The Head of US Commercial & Global Brand Lead , ... of Radio Ligand Therapy in NET and beyond. As ** Global Brand Lead ** you will be accountable...will include managing the increasingly challenging access environment, the regulatory approval process, an increased focus on compliance and… more
    Sanofi Group (10/31/24)
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