• Director, Regulatory Affairs

    BeOne Medicines (Cambridge, MA)
    …and negotiates with FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... including responsibility clinical protocol/safety amendments, supplements, and annual reports; + Drug development process; + FDA regulations; + ICH guidelines;… more
    BeOne Medicines (07/03/25)
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  • Regulatory Affairs Specialist

    Envista Holdings Corporation (Brea, CA)
    …for authoring department standard operating procedure (SOPs). + Responsible for FDA /Canadian device/ drug establishment registrations and device/ drug listings ... required). + Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: FDA , HC, EU and ROW). + Provide regulatory … more
    Envista Holdings Corporation (06/03/25)
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  • Staff Regulatory Affairs Specialist, Mako…

    Stryker (Weston, FL)
    …classification, jurisdiction assessment, and risk mitigation planning. + Prepare and submit regulatory documentation (eg, FDA submissions, EU design dossiers) to ... We are currently seeking a **Staff Regulatory Affairs Specialist** to join our Mako and...is required. + 4+ years of experience in an FDA regulated industry required; preferably with medical devices. +… more
    Stryker (08/08/25)
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  • Director, Global Regulatory Lead, GI…

    Takeda Pharmaceuticals (Boston, MA)
    … submissions. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
    Takeda Pharmaceuticals (08/08/25)
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  • Regulatory Affairs Specialist II…

    Abbott (Plymouth, MN)
    …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, international regulations and other regulatory ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
    Abbott (08/01/25)
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  • Senior Manager, Regulatory Operations

    Sumitomo Pharma (Lincoln, NE)
    …Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). + ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
    Sumitomo Pharma (07/18/25)
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  • Regulatory Affairs Manager - International…

    Abbott (Alameda, CA)
    …actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, operating ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work...5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II,… more
    Abbott (06/21/25)
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  • Director Regulatory Affairs Alliance…

    Lundbeck (Deerfield, IL)
    …documentation to support investigational and marketing registration packages for the US FDA . + Partner with alliance regulatory colleagues regarding submission ... sciences. + Masters. Doctorate Degree or MBA, other professional certifications. + FDA interaction experience. + Exposure to international regulatory affairs,… more
    Lundbeck (06/14/25)
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  • Director Global Regulatory Affairs

    Fresenius Medical Center (Waltham, MA)
    …commercialization of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory ... timely approval and market access across key regions (eg, FDA , EMA, Health Canada, etc.). Including global chemistry, manufacturing,..., EMA, HC, etc.). + Strong expertise in navigating regulatory pathways for drug strategy, from preclinical… more
    Fresenius Medical Center (06/14/25)
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  • Global Regulatory Director

    Edgewell Personal Care (Allendale, NJ)
    …+ Sound knowledge of the consumer products industry. + Experience with OTC drug regulations for FDA , Health Canada, and TGA. Medical devices's regulations ... the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing,… more
    Edgewell Personal Care (06/03/25)
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