- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … more
- 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
- J&J Family of Companies (Titusville, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located ... Director , Global Regulatory Leader...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… more
- J&J Family of Companies (Titusville, NJ)
- …recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs , supporting programs in the Immunology Therapeutic ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be...strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory… 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 ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...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. + 8 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)
- …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
- J&J Family of Companies (Skillman, NJ)
- …Associate, Regulatory Affairs , Dietary Supplements This position reports to the Director , Regulatory Affairs and is based in Skillman. **Who we are** ... Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue...Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse… 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
- J&J Family of Companies (Titusville, NJ)
- …* MA/MPH preferred **Required:** * 5 years in the pharmaceutical industry * 2 years in Regulatory Affairs or Policy * 2 years of direct or indirect management of ... Director , Regulatory Policy and Intelligence Research...* Experience at Health Authority * Understanding of the global regulatory environment, including in US, EU,… more
- Sanofi Group (Bridgewater, NJ)
- …and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... for chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** + The Global Medical Director of Rheumatology, reports to the … more
- J&J Family of Companies (Raritan, NJ)
- Director , Global Strategic Marketing, Lung Cancer - 2406211203W **Description** Johnson & Johnson Innovative Medicine is recruiting for a second Director , ... our people can reach their potential. At Johnson & Johnson, we all belong. The Director , Global Strategic Marketing, Lung Cancer reports to the Sr. Director ,… more
- Sanofi Group (Bridgewater, NJ)
- …clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop ... gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical Head of… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Sanofi Group (Bridgewater, NJ)
- …clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop ... world. **Job Responsibilities:** + The Early Pipeline Respiratory Medical Director reports to the Global Medical Head...required + Experience in pipeline, clinical development and/or medical affairs on a global or regional level… more
- J&J Family of Companies (Raritan, NJ)
- …Development, Medical Affairs , Clinical Research, Regional HEMA & Marketing, Regulatory Affairs , HCC and Legal. Specific responsibilities include: * Lead ... Director , Health Economics and Market Access - Robotics...HEMA for Energy/Endomech/Robotics, will work in close collaboration with Global Strategic Marketing, Research & Development, Medical, Clinical &… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more