- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Merck & Co. (Rahway, NJ)
- … Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Job DescriptionOur Regulatory Affairs team bring new medical...Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to optimize label and… more
- Merck & Co. (Rahway, NJ)
- … Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Job DescriptionOur Regulatory Affairs team bring new medical...Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to optimize label and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned ... and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to...Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Mondelez International (East Hanover, NJ)
- …for assistance. **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality, Safety and Compliance At Mondelēz International, our ... with cross functional partners and provide guidance to business teams and product development on appropriate regulatory compliance and labeling for… more
- Haleon (Warren, NJ)
- …with multiple departments to achieve a product fit for the public. Regulatory Affairs continuously needs to monitor for changes being introduced, provide ... goal. Right now, we're looking for Co-Ops student in Regulatory Affairs to join us to do...Affairs plays a critical role in managing the product life cycle, starting from development process to its… more
- Merck (Rahway, NJ)
- … 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 (Rahway, NJ)
- … 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
- L'Oreal USA (Clark, NJ)
- …+ Strong working knowledge of chemistry (preferred) + 1-3 years' experience in regulatory and/or product safety in cosmetics, personal care, chemical ... Home (https://careers.loreal.com/en\_US/content/Home) / Job Search (https://careers.loreal.com/en\_US/jobs/SearchJobs) / 187151 Scientist, Regulatory Affairs , L'Oreal Research & Innovation Clark,… more
- Englewood Lab, Inc (Totowa, NJ)
- Reports to: Manager of Regulatory Affairs Responsibilities: + Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory ... of Head of R&D (or designee), create and collate product master files (dossiers), drug master files (DMF). +...of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, … 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
- Vantage Specialty Chemicals (Fairfield, NJ)
- …it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading the ... Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs . The person will be responsible for personal care, cosmetic… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Englewood Lab, Inc (Totowa, NJ)
- Responsibilities + Assist the Manager during cGMP, Environmental, and Regulatory audits. + Assist the Manager to create and collate product master files ... CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, RM Safety Data Sheet, RM technical documents, RM composition breakdown, as may be… more
- AbbVie (Florham Park, NJ)
- …IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and scientific strategic and operational ... input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of clinical and scientific data eg,… more
