- 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
- 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
- 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
- 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
- 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
- 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 (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
- 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
- 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
- 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
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