• Senior Regulatory Coordinator

    Dana-Farber Cancer Institute (Brookline, MA)
    … Clinical Trials Office to complete the regulatory requirements of the clinical research project . The RC coordinates aspects of protocol submissions, ... regulations, regulatory guidance and or local policies + Assists Clinical research Manager with regulatory based training and implementation of new… more
    Dana-Farber Cancer Institute (09/20/25)
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  • Regulatory Coordinator - HM Pediatrics

    Dana-Farber Cancer Institute (Brookline, MA)
    … Clinical Trials Office to complete the regulatory requirements of the clinical research project . The RC coordinates aspects of protocol submissions, ... regulations, regulatory guidance and or local policies + Assists Clinical research Manager with regulatory based training and implementation of new… more
    Dana-Farber Cancer Institute (09/13/25)
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  • Director, Regulatory Affairs

    Sumitomo Pharma (Boston, MA)
    …understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical ... Research & Development Activities + As a Regional Regulatory Lead, manage regional (United States and/or European) ...of the Global Regulatory Team (GRT), leads regulatory activities for assigned project (s) in line… more
    Sumitomo Pharma (09/09/25)
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  • Associate Director, Regulatory Affairs…

    Sumitomo Pharma (Boston, MA)
    …of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical ... requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and...Health Authorities + Assist with development of the global regulatory functional plan through research , review and… more
    Sumitomo Pharma (10/11/25)
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  • Associate Director, Patient-Centered Outcomes…

    AbbVie (Waltham, MA)
    …and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Associate Director, Patient-Centered Outcomes Research , will ... with other product team members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs, Medical… more
    AbbVie (09/17/25)
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  • Senior Principal Regulatory Affairs…

    Bausch + Lomb (Boston, MA)
    …clinical , labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical , labeling,… more
    Bausch + Lomb (09/06/25)
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  • Senior Manager, Regional Regulatory Lead…

    CSL Behring (Waltham, MA)
    …related development teams, including critical partners, in research , clinical development, commercial development, business development, project management ... as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed. Within GRAST, effectively foster two-communication between GRAST… more
    CSL Behring (10/01/25)
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  • Clinical Lead, Early Clinical…

    Sanofi Group (Cambridge, MA)
    …+ External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical ... possible. Ready to get started? **Main Responsibilities** **At the project level, the Clinical Lead, ECET will...Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial… more
    Sanofi Group (10/07/25)
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  • Director, Global Regulatory Affairs…

    Sanofi Group (Cambridge, MA)
    …active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase ... regional labeling (eg, US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and… more
    Sanofi Group (10/15/25)
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  • Senior Director, Clinical Trials Office

    Dana-Farber Cancer Institute (Brookline, MA)
    …and functions include clinically facing clinical research management; regulatory affairs; training and education; and project management and monitoring ... across core CTO functions targeting non-faculty members of the study team: clinical research coordinators, regulatory operations, and research… more
    Dana-Farber Cancer Institute (09/19/25)
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