• Manager, Global Regulatory…

    Sanofi Group (Morristown, NJ)
    **Job Title:** Manager, Global Regulatory Affairs - CMC - Vaccines **Location** : Swiftwater, PA or Morristown, PA **About the Job** Are you ready to ... critical in helping our teams accelerate progress. The Manager, Global Regulatory Affairs - CMC has the responsibility of one or several… more
    Sanofi Group (05/22/25)
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  • Global Regulatory Affairs…

    Sanofi Group (Morristown, NJ)
    …development and marketed product objectives. + Represent GRA CMC on GRAT ( Global Regulatory Affairs Team) + Assures effective involvement with change ... The team responsibilities include but are not limited to: global regulatory CMC strategies, submission...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
    Sanofi Group (05/22/25)
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  • University Recruiting- Global…

    Merck (Rahway, NJ)
    …a chance to see if we are the right company for your long-term goals Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing ... CMC regulatory submission strategies and timelines for...organize LoQs + Analyze and trend; develop metrics + Regulatory Affairs Detailed Application Verification (DAV)- verification,… more
    Merck (05/15/25)
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  • Senior Manager, CMC Global…

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of… more
    Otsuka America Pharmaceutical Inc. (04/25/25)
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  • GRA Device Lead

    Sanofi Group (Morristown, NJ)
    …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
    Sanofi Group (04/15/25)
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  • GRA Device Lead, Associate Director

    Sanofi Group (Morristown, NJ)
    …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... key regulatory activities and report to the Global Regulatory Device Head for Digital Health...will work closely with key stakeholders including clinical, medical affairs , Industrial Affairs (Device Development, manufacturing, quality,… more
    Sanofi Group (05/15/25)
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  • Senior Scientist/Associate Director,…

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with… more
    Daiichi Sankyo Inc. (05/15/25)
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  • Regulatory Affairs Professional,…

    J&J Family of Companies (Raritan, NJ)
    … Certificates and Samples - Business Support will contribute to the development of global CMC regulatory strategies with reference to Certificate and Sample ... & Johnson Innovative Medicine R&D is recruiting for a Regulatory Affairs (RA) Professional, CMC ...orders for registration samples, working with regional and local regulatory affiliates and Global Supply Chain personnel.… more
    J&J Family of Companies (05/17/25)
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  • Senior Manager, Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
    Otsuka America Pharmaceutical Inc. (04/23/25)
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  • Senior Global Medical Affairs Leader

    J&J Family of Companies (Raritan, NJ)
    …of all global oncology PAA programs working with R&D, medical affairs , market access, real world evidence, regulatory , CMC , pharmacovigilance, ... every step of the way. Learn more at https://www.jnj.com/innovative-medicine The Senior Global Medical Affairs Leader (Sr. GMAL) for oncology pre-approval access… more
    J&J Family of Companies (05/20/25)
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