• Global Regulatory Affairs…

    Sanofi Group (Morristown, NJ)
    **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
    Sanofi Group (10/15/25)
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  • Global Regulatory Affairs…

    Sanofi Group (Morristown, NJ)
    **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a… more
    Sanofi Group (10/09/25)
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  • CMC Regulatory Affairs…

    Parexel (Trenton, NJ)
    Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
    Parexel (10/11/25)
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  • GRA Device Lead (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 ... 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 (10/13/25)
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  • Senior Regulatory Affairs Associate,…

    Parexel (Trenton, NJ)
    …development and approved programs, helping to shape the future of life-saving therapies. As a ** CMC Regulatory Affairs Senior Associate** , you will play a ... lifecycle management. **Key Responsibilities** + Develop and implement comprehensive global CMC regulatory strategies for...(advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the… more
    Parexel (10/11/25)
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  • Associate Principal Scientist, Regulatory…

    Organon & Co. (Jersey City, NJ)
    … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
    Organon & Co. (10/14/25)
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  • Associate Director, Regulatory…

    Sumitomo Pharma (Trenton, NJ)
    …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
    Sumitomo Pharma (10/11/25)
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  • Director, Regulatory Affairs

    Sumitomo Pharma (Trenton, NJ)
    …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
    Sumitomo Pharma (09/09/25)
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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. (08/22/25)
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  • Senior Principal Regulatory Affairs…

    Bausch + Lomb (Trenton, NJ)
    …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a… more
    Bausch + Lomb (09/06/25)
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