• Senior Manager, Regulatory Operations

    Sumitomo Pharma (Boston, MA)
    …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
    Sumitomo Pharma (07/18/25)
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  • Director Global Regulatory Affairs

    Fresenius Medical Center (Waltham, MA)
    …pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions . + Collaborate with senior leadership in ... and potential risks to inform decision-making across the organization. + **Global Regulatory Submissions :** + Oversee the planning, preparation, and execution of… more
    Fresenius Medical Center (06/14/25)
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  • Senior Manager, Regulatory Affairs CMC…

    AbbVie (Waltham, MA)
    …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
    AbbVie (07/25/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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  • Senior Principal, Regulatory Affairs…

    Danaher Corporation (Boston, MA)
    …registration activities for the respective medical products + Develop and manage regulatory submissions (eg, 510(k), PMA, EU Technical Files, STED), including ... submissions . + Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience… more
    Danaher Corporation (07/09/25)
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  • Director, Global Regulatory Affairs,…

    Takeda Pharmaceuticals (Boston, MA)
    … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions . + Solid working knowledge of drug development… more
    Takeda Pharmaceuticals (07/02/25)
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  • Sr. Regulatory Affairs Specialist - ACM

    Medtronic (Mansfield, MA)
    …requirements + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and ... more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and… more
    Medtronic (07/01/25)
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  • Senior Director, Global Regulatory Lead, GI…

    Takeda Pharmaceuticals (Boston, MA)
    … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... experience. + Experience in reviewing, authoring, or managing components of regulatory submissions . + Expert knowledge of drug development process and … more
    Takeda Pharmaceuticals (05/21/25)
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  • R&D Regulatory Manager

    Grifols Shared Services North America, Inc (Fall River, MA)
    …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
    Grifols Shared Services North America, Inc (05/02/25)
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  • Senior Regulatory Affairs Specialist

    Hologic (Marlborough, MA)
    …with R&D, Quality, Clinical, and Marketing, you will prepare and manage regulatory submissions , technical files, and documentation to meet US, EU, ... ideally with capital equipment products + Proven expertise preparing and maintaining regulatory submissions and technical files for mature and evolving products… more
    Hologic (07/19/25)
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