• Manager, Quality Assurance & Regulatory

    Tecomet (Woburn, MA)
    …as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR Registrations + ... Host FDA and government and notified regulatory agencies audits. + Review and interpret regulatory...ACTION EMPLOYER / PROTECTED / VETERANS / DISABILITIES / DRUG FREE WORKPLACE** **TRAVEL REQUIREMENTS:** X **YES** **NO** **INTENT… more
    Tecomet (07/31/25)
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  • Regulatory Coordinator - Gynecologic…

    Dana-Farber Cancer Institute (Brookline, MA)
    …reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, ... documents for SRC and IRB review and approval + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious… more
    Dana-Farber Cancer Institute (07/23/25)
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  • Associate Director, Global Regulatory

    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. ... bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more
    Takeda Pharmaceuticals (08/08/25)
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  • Executive Director, Regulatory Affairs…

    Regeneron Pharmaceuticals (Cambridge, MA)
    …Director might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and ... through lifecycle management. + Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for investigational and commercial… more
    Regeneron Pharmaceuticals (07/11/25)
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  • 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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  • 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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  • Senior Manager, Regulatory Operations

    Sumitomo Pharma (Boston, MA)
    …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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  • 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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  • Director, Regulatory Advertising…

    Sumitomo Pharma (Boston, MA)
    …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
    Sumitomo Pharma (07/08/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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