- 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
- 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
- AbbVie (Florham Park, NJ)
- …Medical Information (MI) materials. + Participates in design and execution of clinical trial safety , product safety and risk management plans. Track RMP ... medical and scientific strategic and operational input into core medical affairs activities such as: health care professional and provider interactions (Payers,… more
- AbbVie (Florham Park, NJ)
- …product ) strategies, and to support medical/marketing activities (promotional material generation/ product launches) and market access. Drives Medical Affairs ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- AbbVie (Florham Park, NJ)
- …discovery, statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison with other corporations when ... medical and scientific strategic and operational input into core medical affairs activities such as: health care professional and provider interactions (Payers,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …will serve as a strategic legal partner to BD's Regulatory , Quality, Medical Affairs , Sales and Marketing, and Product Development teams. This is a unique ... as a strategic legal partner to BD's Regulatory , Quality, Medical Affairs , Sales and Marketing, and Product Development teams. **Responsibilities:** +… more
- Danaher Corporation (New York, NY)
- …reporting. This role is crucial in maintaining high standards of medical safety , compliance, and regulatory adherence at Beckman Coulter Diagnostics. ... the role involves significant cross-functional interactions, coordination with quality and regulatory teams, oversight of external safety boards as needed,… more
- Bristol Myers Squibb (Madison, 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …consensus on benefit-risk analysis, safety conclusions, and their impact for product safety profile. + Mentor junior pharmacovigilance (PV) personnel in ... correspondence for all assigned. **Responsibilities** + Partners with Medical Directors, Global Safety Team (GST) Chair to provide strategic product risk… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned ... immune disorders. **Summary** This 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