- 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
- 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... with immunologic, hematologic, and other complex diseases. The Director, Global Labeling Strategy Lead is a key...Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling,… 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
- 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- Sumitomo Pharma (Trenton, NJ)
- …+ As a Regional Regulatory Lead , manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT) + As ... Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in...(GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory … more
- Taiho Oncology (Princeton, NJ)
- …be assigned to lead /support one or two clinical development programs as Regulatory Lead (RL), responsible for regulatory strategy and execution ... affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides ...well in a team environment and the ability to lead and influence others. + Ability to: + Read,… more
- Bristol Myers Squibb (Princeton, NJ)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… more
- Integra LifeSciences (Princeton, NJ)
- …The successful candidate will also be responsible for continuously monitoring the global regulatory landscape for new and evolving ESG-related regulations, such ... global or multinational organization with exposure to diverse regulatory environments. + Experience in a multi-national manufacturing and distribution… more
- Bausch Health (Bridgewater, NJ)
- … category management and strategy of the Marketing category. RESPONSIBILITIES The Procurement Global Category Lead - Marketing is an individual contributor role ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...industry standards, and legal regulations. + Liaise with Legal, Regulatory , Finance, IT and other functions as needed. KEY… more
- Zoom (Trenton, NJ)
- Global Healthcare Industry Marketing Lead What you can expect Zoom is looking for a healthcare marketing leader to define and execute the strategic go-to-market ... sales teams, and partners to address industry-specific needs, certifications, regulatory requirements, and integration opportunities. + Develop healthcare use cases,… more
- Merck (Trenton, NJ)
- …**Primary responsibilities include, but are not limited to:** + Serve as the Regulatory Project Lead for assigned device and combination products, guiding ... NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings. + Lead the development, communication, and review of Regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- …and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and ... device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling… more
- Novo Nordisk (Plainsboro, NJ)
- …as East Coast Hub (ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives + Lead a team of Role-Specific Training Support ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Therapeutic Areas). They are responsible to ensure alignment to global and HR training and onboarding plans. They will… more
- Integra LifeSciences (Princeton, NJ)
- …The Labeling Associate will collaborate with cross-functional teams, including Marketing, Regulatory , Quality Assurance, R&D, and Global Operations, to define ... labeling, ensuring compliance with both internal corporate standards and external regulatory requirements. This role will be assisting the strategic and tactical… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …development and commercialization of new and innovative therapies. Assigned to one or more global product(s), or as the lead for a disease area within GEO, ... evidence generation sub team for products under development, and working with global , regional and local cross-functional colleagues lead the development 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