- Ampcus inc (Titusville, NJ)
- …including: Partnership across Medical Affairs , RW V&E, JRD, Brand Marketing, Regulatory Affairs , Global Medical Affairs , New Business Development, ... to join our talented Team. Job Title: Manager ( Medical Affairs )Location(s): Titusville, NJThe Associate Medical Director, Schizophrenia has responsibility for… more
- Careerbuilder-US (Princeton, NJ)
- …into narrative text. Liaises with internal groups, ie, Biostatistics, Data Management, Regulatory Affairs , Medical Affairs , Clinical Development, Clinical ... person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for … more
- Terumo Corporation (Somerset, NJ)
- …this position may assist with directing changes in company policy to ensure product safety , product effectiveness, ethical behavior &/or compliance with ... product recall from the market, to litigation, &/or regulatory action by the FDA to address the situation....CIOs, Directors, Management staff & associates in HR, Quality, Regulatory Affairs , Clinical Affairs , Facilities… more
- Merck (North Wales, PA)
- … Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** Our Regulatory Affairs team bring new medical...Associate Vice President, Therapeutic Area Lead. + Develops worldwide product regulatory strategy to optimize label and… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... grow and expand. Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The ...through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The… more
- Merck (North Wales, PA)
- … Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** Our Regulatory Affairs team bring new medical...or Associate Vice President, General Medicine + Develops worldwide product regulatory strategy to optimize label and… more
- Abbott (Princeton, NJ)
- …submission to US FDA. + Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions. + ... in the Abbott Point of Care Division. As a ** Regulatory Affairs Manager** , your role involves...develop and manage regulatory professionals. + Provide regulatory input to product lifecycle planning. +… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Affairs Manager/Personal Care Princeton, NJ, US Hybrid Are you passionate about the cosmetic and OTC sunscreen regulations in North America with a ... centric mindset? Join us in our journey! As a Regulatory Affairs Manager North America (NA), you...and personal care specialty chemicals products are evaluated for safety and regulatory conformance + Support the… more
- Bausch Health (Bridgewater, NJ)
- …business acumen and the ability to see business drivers outside of regulatory affairs + Working knowledge of the Rx product NDA and labeling processes + ... and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and… more
- Ascendis Pharma (Princeton, NJ)
- …global strategies and local regulations . Coordinate US labeling activities for regulatory submissions, product maintenance and safety variations, including ... a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling… more
- US Tech Solutions (Titusville, NJ)
- …including: + Partnership across Medical Affairs , RW V&E, JRD, Brand Marketing, Regulatory Affairs , Global Medical Affairs , New Business Development, J&J ... work force. Adherence to project budgets and timelines, the safety and privacy of research participants, and compliance with...Doctorate, PhD, or PharmD + Will be monitoring trials, regulatory affairs , etc with competition + Will… more
- FFP (Marlton, NJ)
- …ensuring compliance with regulatory requirements in the areas of food safety , labeling, and product registrations. This position requires a thorough ... submit regulatory documentation, including ingredient listings, food safety plans, and product registration files. +...+ Bachelor's degree in a related field (Food Science, Regulatory Affairs , etc.) + 2+ years of… more
- Bristol Myers Squibb (Princeton, NJ)
- …Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and ... Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and… more
- Bristol Myers Squibb (Princeton, NJ)
- …Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings ... activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s). + Oversee aggregate safety review… more
- Terumo Medical Corporation (Somerset, NJ)
- …to management on pricing, manufacturing, packaging, distribution, promotion, market research, regulatory , legal and any issue which impacts product ... initial installation and maintenance of products. + Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas for Medical & Scientific Affairs (MSA) and Quality Assurance & Regulatory Affairs (QARA) activities. Responsible for managing a broad range of complex ... principal assistant to the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs . Responsible...relationships. + Takes a lead position on the Global Product Recall Committee that assesses and determines if any… more
- Terumo Medical Corporation (Somerset, NJ)
- …& Safety and Quality System policies, programs, rules and practices, taking account product and patient safety , the health and safety of all associates ... NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets… more
- Pfizer (Collegeville, PA)
- …CMAO, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, Market Access, Business ... **ROLE SUMMARY** **The Platform:** The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is...Pfizer's ability to determine unmet medical needs; support differentiated product labels for Product Development programs including… more
- Terumo Medical Corporation (Somerset, NJ)
- …this position may assist with directing changes in company policy to ensure product safety , product effectiveness, ethical behavior &/or compliance with ... product recall from the market, to litigation, &/or regulatory action by the FDA to address the situation....CIOs, Directors, Management staff & associates in HR, Quality, Regulatory Affairs , Clinical Affairs , Facilities… more
- Sanofi Group (Bridgewater, NJ)
- …Collaborate with colleagues in Medical Affairs , Commercial, Research and Development, Drug Safety , Sales & Marketing and Regulatory to ensure success of the ... review and approval of medical and scientific content of Regulatory , Safety , Scientific Affairs , Medical...across brands (where possible) measurable policies regarding customer and product medical education within the team to assure a… more
