• Pharmacy Compliance Coordinator (Full-Time, 8-Hour…

    Stanford Health Care (Palo Alto, CA)
    …front-line staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs,… more
    Stanford Health Care (06/17/25)
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  • Executive Director, US Regulatory

    BeOne Medicines (San Mateo, CA)
    …negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to...in the oncology therapeutic area. + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
    BeOne Medicines (07/27/25)
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  • Senior Manager Regulatory Affairs - Global…

    Abbott (Santa Clara, CA)
    …of medical device regulations and experience such as from the Food and Drug Administration ( FDA ) Center for Devices and Radiological Health (CDRH). This ... + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical regulatory skills to proposed… more
    Abbott (08/08/25)
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  • Regulatory Affairs Specialist II - Ventures…

    Abbott (Santa Clara, CA)
    …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve… more
    Abbott (05/17/25)
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  • Senior Director, Regulatory Affairs - Job…

    Ascendis Pharma (Palo Alto, CA)
    …role involves engaging closely with internal peers and externally stakeholders such as the FDA , EMA, and other key regulatory bodies. The candidate must not only ... regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory ...per year domestically and internationally + Broad experience in Regulatory Affairs, working directly with FDA and… more
    Ascendis Pharma (07/25/25)
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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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  • Senior Manager, Regulatory Operations

    Sumitomo Pharma (Sacramento, CA)
    …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 Advertising…

    Sumitomo Pharma (Sacramento, CA)
    …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. (Sacramento, CA)
    … 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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