• Head of COA Regulatory Strategy, Patient…

    IQVIA (Wayne, PA)
    …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… more
    IQVIA (07/01/25)
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  • Associate Director, Global Regulatory

    Organon & Co. (Plymouth Meeting, PA)
    …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies,...their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference… more
    Organon & Co. (07/26/25)
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  • Senior Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
    Globus Medical, Inc. (08/02/25)
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  • Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
    Globus Medical, Inc. (06/25/25)
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  • Director Regulatory Advertising & Promotion

    J&J Family of Companies (Horsham, PA)
    …subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines ... pharmaceutical or biopharmaceutical industry is required. + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and… more
    J&J Family of Companies (08/08/25)
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  • Regulatory Associate

    Globus Medical, Inc. (Audubon, PA)
    …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
    Globus Medical, Inc. (06/25/25)
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  • Clinical Research Regulatory Specialist B…

    University of Pennsylvania (Philadelphia, PA)
    … Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable ... NCI and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected… more
    University of Pennsylvania (08/03/25)
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  • Senior Manager, Regulatory Operations

    Sumitomo Pharma (Harrisburg, PA)
    …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory more
    Sumitomo Pharma (07/18/25)
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  • Director, Regulatory Advertising…

    Sumitomo Pharma (Harrisburg, PA)
    …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... 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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  • Director/Principal Scientist, Regulatory

    Merck (North Wales, PA)
    …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... + Experience leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated success in managing regulatory filings across… more
    Merck (08/02/25)
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