- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in...possible. Ready to get started? **Main responsibilities:** + Represents Global Regulatory Affairs (US RA… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on… more
- Bausch Health (Bridgewater, NJ)
- …and regulatory agency guidance. Responsibilities: + Manages or represents Regulatory Affairs on the promotional review committees for prescription products ... Bausch Health is a global company that develops, manufactures, and markets a...new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Bausch Health is a global company that develops, manufactures, and markets a...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 7 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Responsibilities** + Ensure global regulatory plans support a precision medicine approach eg ... HA engagement plans and mitigation strategies. + Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device ... aspects of registration activities with a working knowledge of regulatory affairs , in the development of the...effectively in a multidisciplinary team. + Experience working with global regulatory agencies. + Demonstrated business acumen… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Senior Manager, US Advertising & Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** Under the ... direction of the Director , this individual will...possible. Ready to get started? **Main responsibilities** + Represent Global Regulatory Affairs (GRA) US… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and immune disorders. **Summary** With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... of Dossier Planning will report to Head of Global Regulatory Operations and be an active...Regulatory operations required. + 4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Sanofi Group (Bridgewater, NJ)
- …+ Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team ... products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within … more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Global Medical Director , Amlitelimab **Location:** Cambridge, MA or Bridgewater, NJ Within the Global Medical Affairs Immunology team, we ... our Global Medical Immunology team as the Global Medical Director , Amlitelimab and you'll provide...+ Provide leadership and strategic direction to local Medical Affairs teams on launch preparation, educational, and training activities… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …oncology franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Global Senior Medical Director , Asthma **Location:** Cambridge, MA or Bridgewater, NJ Within the Global Medical Affairs team, we are proud ... accelerate progress. Join our Global Medical Immunology team as the Senior Global Medical Director , Asthma and you'll provide impactful medical strategy and… more
- J&J Family of Companies (Raritan, NJ)
- …2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader (1 of 2) in Raritan, NJ; ... Associate Director , Global Labeling Product Leader (1...experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Senior Director , Global Medical Affairs Operations Excellence will report ... and Execution - Oncology and supporting the Vice President of Global Medical Affairs - Oncology. The Senior Director will play a critical role in shaping… more