- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory ... you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable… more
- Bristol Myers Squibb (Princeton, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Affairs Lead ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The Global Regulatory Affairs Lead ... maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's diversified portfolio… more
- Sanofi Group (Bridgewater, NJ)
- …what you thought was possible. Ready to get started? **Main responsibilities:** + As the Global Regulatory Affairs CMC Lead for Influenza, you will be ... of the regulatory aspects of influenza team. + Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). ... + Serve as team lead or co- lead of marketing application submission...+ Ensure global development plans will meet global regulatory requirements by soliciting and integrating… 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 ... to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the… 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
- Sanofi Group (Bridgewater, NJ)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL) , the Regulatory Strategist (RS) leverages ... on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position on… more
- Sanofi Group (Bridgewater, NJ)
- …disease. The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL). We are an innovative global ... teams to ensure the delivery of business objectives. + The RS enables the Global Regulatory Lead (GRL) to provide regulatory position to support business… more
- Insight Global (Raritan, NJ)
- Job Description Insight Global is seeking a Global Regulatory Labeling Product Lead to join a large Pharmaceutical client. This role will support Pharma ... products specifically in the Global Labeling department. Key responsibilities include developing target labeling, managing updates to Company Core Data Sheets… 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 topics, including… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise ... to contribute to the definition of the global regulatory strategy, to enable and drive...governance, and committees + May serve as a regional/local regulatory lead and point of contact with… 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) ... global health authority query (HAQ) tracker and archiving regulatory correspondences + Support DSUR/PBRER preparation by attending Kick-off Meeting, coordinating… 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 will be...for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling… more
- Bausch Health (Bridgewater, NJ)
- …CAPAs. **KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on ... and impact. **OBJECTIVES/** **PURPOSE OF JOB:** The Senior Director of Global Regulatory Operations is responsible for directing and managing the Regulatory… more
- J&J Family of Companies (Titusville, NJ)
- …Johnson & Johnson Innovative Medicine is recruiting for Associate Director, North America Regulatory Lead in Global Regulatory Affairs, supporting ... of regulatory strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory Team (GRT) and may… more
- Bristol Myers Squibb (Princeton, NJ)
- …practical aspects of global change management. **Position Responsibilities** + Represent regulatory CMC on and/or lead matrix teams for small molecule ... role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in all regions. The Director of Dossier Planning will report to Head of Global Regulatory Operations and be an active participant on the Regulatory ... around rare diseases and immune disorders. **Summary** The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the… 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