• Regulatory Affairs Associate Director, IVD

    GRAIL (Menlo Park, CA)
    …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
    GRAIL (08/16/25)
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  • Associate Director, Global TA Regulatory…

    Gilead Sciences, Inc. (Foster City, CA)
    …Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and International ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
    Gilead Sciences, Inc. (08/02/25)
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  • Regulatory Affairs Project Manager

    Kelly Services (Torrance, CA)
    ** Regulatory Affairs Project Manager (Cosmetics & OTC Drug Industry)** Kelly(R) Science & Clinical s seeking a ** Regulatory Affairs Project Manager** for a ... hires or outsourced support, as needed. **Qualifications** + Minimum 5 years in regulatory affairs within the cosmetics and OTC drug sector; contract… more
    Kelly Services (08/22/25)
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  • Manager, Regulatory Affairs Advertising…

    Gilead Sciences, Inc. (Foster City, CA)
    …or other biologic products. + Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
    Gilead Sciences, Inc. (07/16/25)
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  • Regulatory Affairs Manager - Vascular…

    Abbott (Santa Clara, CA)
    … regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to ... products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, bare metal stents, guide wires, balloon dilatation catheters,… more
    Abbott (07/31/25)
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  • Senior Director, Regulatory Affairs

    Stryker (San Jose, CA)
    …desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements + ... The **Senior Director, Regulatory Affairs** is a key strategist, responsible for...other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance,… more
    Stryker (08/14/25)
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  • Associate Director, MSAT, Downstream Drug…

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
    Otsuka America Pharmaceutical Inc. (07/18/25)
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  • Medical Director - Physician -Early Clinical…

    Lilly (San Diego, CA)
    …and strategy ** Regulatory & Medical Affairs Support** + Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning ... of regulatory requirements for early clinical development (IND strategy, FDA interactions, global regulatory agencies) + Familiarity with target… more
    Lilly (08/16/25)
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  • Sr Embedded Software Engineer

    Abbott (San Diego, CA)
    …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, coding, and… more
    Abbott (07/30/25)
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  • Project Manager I

    Charles River Laboratories (Northridge, CA)
    …meet project goals. + Ensure projects adhere to quality standards and relevant regulatory requirements (eg, GxP, FDA , ISO) **Job Qualifications** + Bachelor's ... We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. At Cell Solutions, we are passionate… more
    Charles River Laboratories (08/08/25)
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