- 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
- 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
- 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
- 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
- Insight Global (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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
- 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 ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Sanofi Group (Bridgewater, NJ)
- …on millions of patients around the world. **Medical Director** **- Global Medical Evidence Generation** supports disease registries, post- regulatory ... Next-Gen Immunology pipeline assets. The Medical Director will report directly to Global Medical Evidence Generation Lead , Next-Gen Immunology Franchise and will… more
- Bank of America (Pennington, NJ)
- Compliance and Operational Risk Specialist - Global Compliance and Operational Risk Charlotte, North Carolina;Dallas, Texas; Pennington, New Jersey; Plano, Texas ... second line of defense compliance and operational risk oversight for Global Compliance and Operational Risk. Key responsibilities include ensuring requirements of… more
- Lilly (Branchburg, NJ)
- …people management experience. + Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. + Prior work Overseeing change ... practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will be expected to lead the Change… more
- Sanofi Group (Bridgewater, NJ)
- …surveillance, signal detection & characterization, safety reporting including for regulatory purpose). Lead cross-functional safety initiatives, drive and ... as key statistical consultant on safety related topic within company and contribute/ lead cross-company initiatives. Manage a global team of statisticians,… more
- Sanofi Group (Bridgewater, NJ)
- …of Immunology and works under the direction of the Dermatology and Rheumatology Global Medical Lead . + You will closely collaborate with cross-functional teams, ... to meet the needs of patients. **Key responsibilities include:** + Support the Global Medical Lead in developing and executing an integrated medical strategy… more
- Sanofi Group (Morristown, NJ)
- …quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable US regulatory and GxP regulatory ... portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax... Regulatory Authorities, in coordination with CHC US Regulatory Affairs, lead /co- lead the support… more
- Bausch Health (Bridgewater, NJ)
- Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, ... drive our collective progress and impact The Senior Director, Global Marketing is responsible for building successful global...and reimbursement. + Forecasting and Budgeting. This role will lead building a revenue and expense forecast for each… more