- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Affairs Lead ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The Global Regulatory Affairs ... relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global ), in early and… more
- Sanofi Group (Bridgewater, NJ)
- …was possible. Ready to get started? **Main responsibilities:** + As the Global Regulatory Affairs CMC Lead for Influenza, you will be responsible for ... biological entities, and/or vaccine products) in collaboration with other parts of Global Regulatory Affairs . + Interpret global regulations &… more
- Bausch Health (Bridgewater, NJ)
- …**KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on the ... progress and impact. **OBJECTIVES/** **PURPOSE OF JOB:** The Senior Director of Global Regulatory Operations is responsible for directing and managing the… more
- Sanofi Group (Bridgewater, NJ)
- …limits of what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the ... **Job title: Global Regulatory Lead ** +...**Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or 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
- 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 ... Associate Director, North America Regulatory Lead - 2406196976W **Description** Johnson...Johnson & Johnson, we all belong. The Associate Director, Regulatory Affairs will be responsible for the… 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
- Taiho Oncology (Princeton, NJ)
- …to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory ... with the US Food and Drug Administration (FDA). + Lead /support Regulatory subteam(s) for assigned projects to...and other product-related teams. Foster and facilitate communication with Global Regulatory Affairs on these… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager** **Position Summary** Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The ... aspects and climate that would affect proposed activities. The Regulatory Affairs Project Manager combines knowledge of...every patient, consumer, and Catalent employee.** **The Role** + Lead the development of regulatory strategy for… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Affairs Manager/Personal Care Princeton, NJ, US Hybrid Are you passionate about the cosmetic and OTC sunscreen regulations in North America with a ... centric mindset? Join us in our journey! As a Regulatory Affairs Manager North America (NA), you...of personal care products and being integrated to the global regulatory team. + Contribute to the… more
- Bausch + Lomb (Bridgewater, NJ)
- …* Bachelor's degree preferred or equivalent. * Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, ... external regulatory stakeholders and shape the external regulatory environment. * Effectively lead /manage projects with...and ability to see the business drivers outside of Regulatory Affairs . * Ability to influence internal… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) ... research areas centered around rare diseases and immune disorders. **Summary** The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides… 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 ... of US regulatory submissions and provide US regulatory support across all global projects; meet...negotiate and orchestrate meetings and teleconferences with FDA + Lead and prepare FDA submissions, including but not limited… more
- Ascendis Pharma (Princeton, NJ)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... The Regulatory Affairs (RA) Associate Director, Labeling...for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling… 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 ... of US regulatory submissions and provide US regulatory support across all global projects; meet...archiving. Serve as the primary contact with FDA. + Lead and prepare FDA submissions, including but not limited… 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
- Bristol Myers Squibb (Princeton, NJ)
- …teams on practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline ... through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …preparation of challenging communications + Manage the preparation for interaction with global regulatory authorities (eg, meetings, IR responses, inspections) + ... following:** + Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase,... RA in a timely manner + Participate in global RA meetings, provide regulatory interpretation, position,… more
- Abbott (Princeton, NJ)
- …of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global Marketing & Commercial teams ... Work On** + Reporting directly to the Sr. Director, Global Medical & Scientific Affairs (GMSA), Abbott...of strategic initiatives. . Ensures team member adherence to regulatory and compliance guidelines in all aspects of scientific… more
- Syensqo (Princeton, NJ)
- …with government stakeholders. This position, reporting directly to the Vice President, Global Government Affairs , is responsible for supporting the development ... implementation. + Mobilize US employees on various advocacy issues when necessary. + Lead coordination and filing of NA Government Affairs Department's US… more