• Regulatory Submission Lead

    Sanofi Group (Morristown, NJ)
    **Job Title:** Regulatory Submission lead **Location:** Morristown, NJ/ Cambridge MA **About the Job** Are you ready to shape the future of medicine? The ... be critical in helping our teams accelerate progress. The Submission Lead is responsible for the planning,...is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at… more
    Sanofi Group (09/06/25)
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  • Programming Project Leader

    Sanofi Group (Morristown, NJ)
    …and leadership to metadata specifications and project/study specific data requirements + Lead regulatory submission activities, including electronic ... (ie statistical concepts, techniques and clinical trial principles) and ability to lead regulatory submissions + Ability to collaborate with external partners… more
    Sanofi Group (09/04/25)
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  • Associate Director, Statistics - (Hybrid)

    AbbVie (Florham Park, NJ)
    …multiple disciplines to advance medicines to our patients. Responsibilities: + Provide expertise/ lead regulatory submission and product life-cycle management ... regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory … more
    AbbVie (08/30/25)
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  • Regulatory Strategist

    Sanofi Group (Morristown, NJ)
    …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... as well as for lifecycle management of products. + May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their… more
    Sanofi Group (09/06/25)
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  • Manager, Regulatory Program Manager…

    J&J Family of Companies (Raritan, NJ)
    …risk and opportunity playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team (GRT), including activities ... clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed… more
    J&J Family of Companies (09/05/25)
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  • Associate Director Regulatory Affairs…

    Amneal Pharmaceuticals (Piscataway, NJ)
    … trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee ... in the area of Biosimilar/BLA submissions including strategize, compile, review and manage/ lead regulatory submissions. Subject matter expert in the area of… more
    Amneal Pharmaceuticals (08/15/25)
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  • Staff Regulatory Affairs Specialist

    BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
    … regulatory guidance throughout the product development cycle prior to regulatory submission . + Identify and communicate appropriately quantified risks and ... justifications for changes that do not require a 510(k) submission . + Coordinate and prepare technical files for ...regulatory associates to register our devices worldwide. + Lead regulatory efforts required to follow new… more
    BD (Becton, Dickinson and Company) (07/18/25)
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  • Senior Principal Regulatory Affairs…

    Bausch + Lomb (Trenton, NJ)
    … Regulatory Affairs + Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval + ... the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for...knowledge-sharing initiatives. + Mentor and coach team members in regulatory strategy and submission excellence. + Monitor… more
    Bausch + Lomb (09/06/25)
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  • Senior Principle Scientist, Regulatory…

    Merck (Trenton, NJ)
    …product life cycle. + Oversee and independently lead the preparation, submission , and follow-up of regulatory applications and ensure quality and compliance ... International Regulatory Affairs with prior experience as a Global Regulatory Lead + Demonstrated scientific knowledge, writing ability, effective… more
    Merck (08/23/25)
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  • Associate Director, Global Regulatory…

    Organon & Co. (Jersey City, NJ)
    **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, ... have an external business partner. + Coordinate the preparation, submission , and follow-up contact with regulatory agencies...and associated documentation. + Provide expertise as the Global Regulatory Lead to Product Development Teams and… more
    Organon & Co. (07/26/25)
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