- Novo Nordisk (Princeton, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead . Essential Functions + Serve as a ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… 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
- 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 ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- Merck (Rahway, NJ)
- …of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist /...lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr.… more
- Pfizer (New York, NY)
- …Team(s). As a Director , Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from ... be considered. + Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST. + Advanced knowledge of US… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision Medicine you will ... regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross...and presents to senior leadership as required. + Develops, lead , and communicate a business plan to and implements… more
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for...possible. Ready to get started? **Main responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …activities focused on the USA, alongside coordinating the global team. **Responsibilities** ** Lead and manage a global regulatory intelligence and policy ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...of leading Regulatory Intelligence, this role will lead the development and implementation of a global… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As...prescription drugs, biologics, and devices. We are an innovative global healthcare company with one purpose: to chase 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
- 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
- S&P Global (New York, NY)
- …internal use):** 13 **The Team:** This is a commercial position within S&P Global Market Intelligence, Regulatory Compliance Division. This position will report ... closely with the Sales, Operations, Technology / Product team across Regulatory Compliance. **Responsibilities and Impact:** Our comprehensive services bring greater… more
- Pfizer (New York, NY)
- …benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead will report to the VP, Medical Dermatology ... Global Franchise Lead . The Senior Medical Director will develop...atopic dermatitis disease care gaps, HCP and patient perspectives, regulatory and market access dynamics and integrate these insights… more
- Pfizer (New York, NY)
- …on doing better for Pfizer's patients and healthcare. **ROLE RESPONSIBILITIES** + Proactively lead the development of the Global HTA evidence generation strategy ... + Lead and supervise the design and execution of global HEOR studies (eg, network meta-analyses, non-interventional studies) from concept through publication,… more
- S&P Global (New York, NY)
- **About the Role:** **Grade Level (for internal use):** 12 ** Director , Global Sanctions & Financial Crimes Compliance Program Advisor** **About the Role:** ... **Responsibilities and Impact:** **The Impact:** + The Director , Global Sanctions & Financial Crimes Compliance...management efforts. + Maintain a current awareness of the regulatory environment and emerging Global Financial Crimes… more
- Merck (Rahway, NJ)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or... Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- J&J Family of Companies (Raritan, NJ)
- Director , Regulatory Affairs - 2406188412W **Description**...Global / North American regulatory strategies. Lead the Global Regulatory Team ... **Employer:** Janssen Research & Development, LLC **Job Title:** Director , Regulatory Affairs **Job Code:** A011.5200 **Job...market access strategy, and the Target Product Profile (for global programs as assigned). Lead and/or participate… 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… more