• Senior Counsel, Assistant Vice President of Legal…

    RWJBarnabas Health (West Orange, NJ)
    Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management ... professional experience. Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory Compliance Job Overview: RWJBarnabas Health,… more
    RWJBarnabas Health (07/04/25)
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  • Director/Principal Scientist, Regulatory

    Merck (Rahway, NJ)
    …+ Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory due diligence activities ... chemistry, or related discipline with 10+ years of relevant drug development, clinical , or regulatory experience. + MS with 10+ years of experience. + Ph.D. with… more
    Merck (08/02/25)
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  • Regulatory Affairs - Biosimilar/BLA

    Amneal Pharmaceuticals (Piscataway, NJ)
    …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... Description: Regulatory expert in the area of Biosimilar/BLA submissions...of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject matter expert in the area of… more
    Amneal Pharmaceuticals (05/16/25)
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  • Senior Medical Writer, Global Regulatory

    Ascendis Pharma (Princeton, NJ)
    …years within Medical Writing. Furthermore, you have: + Experience in authoring clinical / regulatory documents. + Excellent verbal and written communication skills ... across time zones. + Ability to understand, interpret and communicate data from clinical trials. + Proven ability to work with and lead cross-functional, global… more
    Ascendis Pharma (07/17/25)
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  • Associate Director, Global Regulatory

    Organon & Co. (Jersey City, NJ)
    …activity and complexity level, as well as post-approval products with limited clinical development + Regulatory product and compliance management (coordinates ... **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global… more
    Organon & Co. (07/26/25)
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  • VP Clinical Development, Oncology

    Sumitomo Pharma (Trenton, NJ)
    …and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical ... data analysis. + Provide medical expertise to cross-functional teams, including regulatory , commercial, and clinical operations. + Provide day-to-day practical… more
    Sumitomo Pharma (05/15/25)
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  • Senior Director, Clinical Lead Alzheimer's…

    J&J Family of Companies (Titusville, NJ)
    …project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, ... on development plans or program-related issues + Working with global clinical operations, Regulatory , and Global Medical Safety, leads the clinical team… more
    J&J Family of Companies (07/22/25)
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  • Director, Clinical Pharmacology Lead

    Bayer (Whippany, NJ)
    … trials. This will involve collaboration with clinicians, clinical operations, bioanalysis, biomarker specialists, pharmacometrics, pharmacovigilance, regulatory ... + Lead and manage the preparation of the CP sections of major clinical and regulatory documents (eg CTDs, NDAs, INDs, IMPDs) and provide global CP submission… more
    Bayer (08/07/25)
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  • Late Stage Oncology Clinical Scientist

    Pfizer (Peapack, NJ)
    …informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical ... abstracts and/or presentations. + Solid understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-… more
    Pfizer (07/29/25)
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  • Senior Director, Global Clinical

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is ... + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in the field to… more
    Otsuka America Pharmaceutical Inc. (07/16/25)
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