- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Global Regulatory Lead **Location** : Bridgewater, NJ / Cambridge, MA (hybrid) **About the Job:** Are you ready to shape the future of ... accelerate progress. Join our Immunology & Inflammation Regulatory Team as Global Regulatory Lead and you'll be responsible for the development &… more
- Novo Nordisk (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a member… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution. + Participate in ... for operational matters. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project. Lead and...global product team meetings to provide US … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Sumitomo Pharma (Trenton, NJ)
- …activities as part of the Global Regulatory Team (GRT) + Supports the global regulatory lead (GRL) in the formulation of regulatory strategy, and ... of **Manager, Regulatory Affairs** . The Manager is part of the Global Regulatory Affairs (GRA) team based in the US and he/she will primarily function as… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and...Cross-Functional Team (GLOC) + In alignment with TAU/MPD Labeling Lead , coordinates the process to obtain IFU labeling approval… more
- J&J Family of Companies (Raritan, NJ)
- …and maintenance of robust Global / North American/ regulatory strategies. + Lead the Global Regulatory Team and be a key contributor on multiple ... & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Leader. This position can be...In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global … 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...or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director, Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Jan 14, 2025 Location: Parsippany, United States, New Jersey, 07005 Company: ... enable people to live better, healthier lives. **The opportunity** As a **Director, in Global Regulatory Medical Writing (GRMW)** , you will primarily work in a… 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...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson is currently seeking a Senior Director, Regulatory Affairs Global Strategy Implementation to join our team preferably located in Raritan, NJ, ... potential. At Johnson & Johnson, we all belong. The Senior Director, Regulatory Affairs Global Strategy Implementation partners with MedTech Surgery business… more
- Sanofi Group (Morristown, NJ)
- …complete, accurate, and aligned with both global and local requirements. Lead strategy development for regulatory authority interactions. + **Drive Program ... ** Global Switch Science Lead (Innovation)** +...requirements across target markets, with demonstrated success in navigating global or regional regulatory environments. + **Clinical… more
- Sanofi Group (Morristown, NJ)
- ** Global Switch Science Lead (ACNU)** + _Location: Morristown, NJ/Hybrid_ **_About the job_** Are you ready to shape the future of Consumer Health? Your skills ... critical in helping our teams accelerate progress. Join our Global Switch Science Lead where you will...to Health Authorities align with the program strategy, meet regulatory requirements, and facilitate efficient review processes. Lead… more
- Sanofi Group (Morristown, NJ)
- …Contribute to global registration dossier development (DSUR/PSUR, PBRER, RMP) and lead risk mitigation strategies to achieve timely regulatory approvals. + ... ** Global Switch Medical Strategy Lead ** +...of switch products, including clinical development, consumer studies, and regulatory processes for switch programs. + ** Global /Regional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Sanofi Group (Morristown, NJ)
- ** Global Medical Lead , Allegra** Location: Morristown, NJ **_About the Job_** Are you ready to make an impact on the world's leading health and wellness brands? ... We are looking for a visionary and dynamic Global Medical Lead to drive innovative strategies and enhance the health and safety of consumers globally. In this… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director, Pipeline Immunology Asset Lead , Global Health Economics, Value, and Outcomes Date: Jan 11, 2025 Location: Parsippany, United States, New Jersey, 07054 ... a difference with. **The opportunity** As the **Director, Pipeline Immunology Asset Lead - ImmunoOncology, GHEVO,** you'll serve as a principal strategic and… more
- Sanofi Group (Morristown, NJ)
- ** Global Commercial Switch Lead ** + Location: Morristown, NJ **_About the Job_** At Sanofi Consumer Healthcare, we build trusted and loved brands that connect ... the best fast-moving consumer healthcare company in and for the world. The Global Commercial Lead for Switch is responsible for driving the pre-commercialization… more
- Sanofi Group (Morristown, NJ)
- ** Global Commercial Switch Lead ** + Location: Morristown, NJ **_About the Job_** At Sanofi Consumer Healthcare, we build trusted and loved brands that connect ... the best fast-moving consumer healthcare company in and for the world. The Global Commercial Lead for Switch is responsible for driving the pre-commercialization… more