• Senior Regulatory Affairs Specialist, Mako…

    Stryker (Mahwah, NJ)
    …various Stryker divisions. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions , interact with ... of FDA, Europe, and international medical device regulations + Experience drafting regulatory submissions for product approval **Preferred** + RAC certification… more
    Stryker (07/28/25)
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  • Principal Scientist, Regulatory Affairs…

    Organon & Co. (Jersey City, NJ)
    …to ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions . This includes assessing CMC changes during development and ... manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage… more
    Organon & Co. (07/22/25)
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  • AD / Dir Regulatory Affairs Strategy

    System One (Florham Park, NJ)
    …timelines and draft submission packages. Performance metrics will include completion of regulatory submissions , adherence to timelines, and the quality of ... intelligence to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies and Submissions with… more
    System One (05/21/25)
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  • Regulatory Operations Specialist

    Integra LifeSciences (Princeton, NJ)
    …Supports Regulatory Management in the preparation and coordination of regulatory submissions . Ensures submission components are accurate, complete, and ... with regulatory submission formats, including eStar, eCTD, and paper submissions . + Proficiency with publishing software and document management systems (eg,… more
    Integra LifeSciences (07/22/25)
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  • Associate Director, Regulatory Affairs

    United Therapeutics (Trenton, NJ)
    …managing documentation and timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are ... the ESG portal + Proven track record in successfully navigating regulatory submissions + Proven ability to lead and influence data-driven strategy planning… more
    United Therapeutics (06/14/25)
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  • Associate Principal Scientist (Associate Director)…

    Merck (Rahway, NJ)
    …Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory Submissions , Technical Writing ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
    Merck (07/19/25)
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  • Associate Director, Regulatory Affairs…

    Merck (Rahway, NJ)
    … Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions , Strategic Thinking, Systems ... and skills:** + Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience strongly… more
    Merck (07/26/25)
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  • Senior Regulatory Compliance/ Quality…

    Robert Half Finance & Accounting (Roselle, NJ)
    … activities across multiple projects to ensure consistency and efficiency. + Regulatory Documentation & Submissions . Requirements The ideal candidate will have ... 401K w/ match Responsibilities: + Serve as the primary regulatory contact across departments including R& D, Quality Assurance,...Minimum 4+ years of regulatory experience in the food or beverage industry. Robert… more
    Robert Half Finance & Accounting (07/22/25)
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  • Associate Director, Global Regulatory

    Sanofi Group (Morristown, NJ)
    …of patient experience data to maximize labeling value. + Assist in labeling submissions , regulatory queries, and updates to ensure compliance with regulatory ... **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...helping our teams accelerate progress. The Associate Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
    Sanofi Group (06/27/25)
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  • Regulatory Affairs Specialist

    Kelly Services (Bridgewater, NJ)
    …+ **Responsibilities** + Provide support for the execution of the pharmaceutical regulatory strategy and submissions for assigned products: Provide support for ... ** Regulatory Affairs Specialist** Kelly Science and Clinical is seeking a ** Regulatory Affairs Specialist** **for** our client a leading medical device company… more
    Kelly Services (07/04/25)
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