• Senior CMC Regulatory…

    Actalent (Parsippany Troy Hills, NJ)
    Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC Regulatory Affairs Scientist, you will play a crucial role in the design and ... + Collaborate with pharmaceutical development and industrial operations teams to generate CMC regulatory dossiers. + Participate in industry working groups to… more
    Actalent (10/11/25)
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  • Senior Regulatory Affairs…

    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 ... scientific discipline (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. +… more
    Parexel (10/11/25)
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  • CMC Regulatory Affairs…

    Parexel (Trenton, NJ)
    …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
    Parexel (10/11/25)
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  • Executive Director, Regulatory CMC…

    Merck (Rahway, NJ)
    … CMC . This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality projects ... as an extension of the overall Regulatory Affairs CMC Leadership Team. This Lead plays a critical role in driving alignment and execution globally across… more
    Merck (10/01/25)
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  • Senior Principal Regulatory…

    Bausch + Lomb (Trenton, NJ)
    …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to… more
    Bausch + Lomb (09/06/25)
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  • Senior Regulatory Affairs…

    Parexel (Trenton, NJ)
    **Join Parexel as a Regulatory Affairs Strategy Lead** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... plans? If so, we'd love to connect. We're seeking Regulatory Affairs Strategy Leads who will be...programs from early development through approval * Coordinate cross-functional regulatory activities ( CMC , nonclinical, clinical) to meet… more
    Parexel (10/11/25)
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  • Senior Principal Regulatory…

    Bausch + Lomb (Trenton, NJ)
    …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... or equivalent; Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, Nutritional,… more
    Bausch + Lomb (09/06/25)
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  • Associate Director, Regulatory…

    Sumitomo Pharma (Trenton, NJ)
    …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
    Sumitomo Pharma (10/11/25)
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  • Director, Regulatory Affairs

    Sumitomo Pharma (Trenton, NJ)
    …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
    Sumitomo Pharma (09/09/25)
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  • Senior Manager, Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
    Otsuka America Pharmaceutical Inc. (08/22/25)
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