• Vice President, Regulatory Affairs…

    Sumitomo Pharma (Trenton, NJ)
    …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
    Sumitomo Pharma (12/23/25)
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  • Pharmaceutical Regulatory & Compliance…

    MetaOption, LLC (Jersey City, NJ)
    …a focus on manufacturing and wholesale distribution. + Proven track record in FDA regulatory compliance, including cGMP, GDP, and DSCSA. + Experience working ... adherence to regulatory standards. Key Responsibilities + Regulatory Compliance Oversight + Advise on FDA ,...and DSCSA (Drug Supply Chain Security Act) requirements. + Quality Systems & Documentation + Establish and maintain SOPs,… more
    MetaOption, LLC (12/24/25)
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  • Regulatory Site Quality Specialist

    Insight Global (Florham Park, NJ)
    Job Description A large CPG client of ours is looking for a regulatory site quality specialist to help with their products OTC drug listing portfolio. This role ... degree in science or engineering -5 years' experience in Regulatory , Quality , R&D or Analytical in a...Analytical in a GMP facility -Experience and understanding of FDA OTC Drug Listing Process -Experience and understanding GMP… more
    Insight Global (12/16/25)
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  • Senior Manager, CMC Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy). + Assess and provide … more
    Otsuka America Pharmaceutical Inc. (12/02/25)
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  • Senior Regulatory Affairs Specialist

    Pentax Medical (Montvale, NJ)
    …+ Work in partnership with manufacturing and QA/QC in designing and enhancing quality management systems to facilitate overall regulatory compliance. + Reviews ... new regulatory developments. + Maintain list of regulatory and quality standards relevant to the...related field (Masters preferred) + Three-five years' experience in Regulatory Affairs for a FDA regulated employer… more
    Pentax Medical (10/24/25)
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  • Director, Regulatory Affairs CMC

    Taiho Oncology (Princeton, NJ)
    …(TPC) and external consultants/contractors. Manages the development and preparation of high- quality regulatory submissions including NDA's, MAA's, INDs, CTAs, ... and other related areas. + In conjunction with Quality Assurance, manages regulatory compliance for sponsor...+ Knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA . + Experience… more
    Taiho Oncology (12/09/25)
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  • Regulatory Affairs Associate Director, IVD

    GRAIL (Trenton, NJ)
    …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
    GRAIL (12/03/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
    Otsuka America Pharmaceutical Inc. (11/20/25)
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  • Associate Director, Regulatory Intelligence

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    …Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses. + Demonstrate understanding of the major ... affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA ...in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and… more
    Otsuka America Pharmaceutical Inc. (11/13/25)
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  • Sr. Scientist II - Regulatory Affairs

    Mondelez International (East Hanover, NJ)
    …are achieved with high quality results and alignment with Legal, Quality , Category managers and Regulatory leads. **Education / Certifications:** Master's ... Rights: Workplace Discrimination is Illegal **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality , Safety and Compliance At Mondelēz… more
    Mondelez International (10/24/25)
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