• Director Global Regulatory Affairs

    Fresenius Medical Center (Waltham, MA)
    …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory more
    Fresenius Medical Center (06/14/25)
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  • Senior Manager and Policy Analyst, US…

    SAP (Washington, DC)
    …and a variety of benefit options for you to choose from. **About Government Affairs ** SAP Government Affairs is SAP's single point of contact for all ... government entities to drive business development and mitigate policy and regulatory risk. We engage with government officials, regulators, legislative bodies, and… more
    SAP (06/03/25)
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  • Regulatory Affairs Assoc II CMC…

    Gilead Sciences, Inc. (Foster City, CA)
    …Join Gilead and help create possible, together. **Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory ... regulatory strategies. + Under the guidance of more senior staff, oversees the preparation of CMC regulatory... senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid… more
    Gilead Sciences, Inc. (07/29/25)
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  • Associate Director, Global Regulatory

    Organon & Co. (Jersey City, NJ)
    …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new legislations, guidelines and ... Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global Therapeutic Area Leader (GTAL),...entire life cycle of the drug. + Represent Global Regulatory Affairs within our company's internal committees… more
    Organon & Co. (07/26/25)
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  • Sr Director, Regulatory Affairs CMC

    Gilead Sciences, Inc. (Foster City, CA)
    …the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises expertise in the ... degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas of at least 14… more
    Gilead Sciences, Inc. (07/25/25)
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  • Advanced Regulatory Affairs

    Bio-Techne (Austin, TX)
    …Pay Range: $62,300.00 - $102,350.00 **Position Summary:** The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory ... Bachelor's degree in related field with 3-5 years of relevant experience in regulatory affairs in an IVD manufacturing environment; Or, a master's degree with up… more
    Bio-Techne (07/25/25)
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  • Director, Regulatory Affairs CMC

    Gilead Sciences, Inc. (Foster City, CA)
    …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior...Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant… more
    Gilead Sciences, Inc. (06/27/25)
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  • Global Regulatory Affairs Chief…

    Takeda Pharmaceuticals (Boston, MA)
    …and tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory ... experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies + Experience in R&D operations… more
    Takeda Pharmaceuticals (05/30/25)
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  • Senior Counsel, Assistant Vice President…

    RWJBarnabas Health (West Orange, NJ)
    Senior Counsel, Assistant Vice President of Legal Affairs , Employee Benefits and ERISA ComplianceReq #:0000206241 Category:Professional / Management ... factors, including the candidate's educational background, skills and professional experience. Senior Counsel, Assistant Vice President of Legal Affairs ,… more
    RWJBarnabas Health (07/04/25)
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  • Senior Manager, Corporate Affairs

    Intuit (Washington, DC)
    …within a regulatory body on financial services issues in a senior capacity, or representing a consumer financial services trade association. + Strong knowledge ... an innovative and strategic policy leader and advocate to join our Global Corporate Affairs and Public Policy (GCAPP) team with a specific focus on Consumer Platform… more
    Intuit (07/17/25)
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