- 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...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned...resolution. + Participate in global product team meetings to provide US … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… 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 Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… 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 ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… more
- Bayer (Whippany, NJ)
- …guidance and category knowledge to US Medical Strategy, Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical ... 832367 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Compliance, Radiology, Regulatory Affairs , Clinical Research, Medical Research, Legal,… more
- Bausch Health (Bridgewater, NJ)
- …of HEOR resources to program teams, clinical development teams, market access, and medical affairs teams. + Providing a forum for global HEOR alignment and best ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...drive our collective progress and impact. As a Senior Director in Health Economics and Outcomes Research (HEOR), you… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can be located in Spring House, PA; Horsham, PA; ... potential. At Johnson & Johnson, we all belong. The Director , Global Regulatory Leader, is...strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access… more
- Sanofi Group (Bridgewater, NJ)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... **Job Title:** Medical Director - Global Medical Evidence Generation...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Sanofi Group (Bridgewater, NJ)
- …and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... for chronic dermatologic, respiratory, and gastrointestinal diseases. **Position Summary** + The Global Medical Director of Dermatology, reports to the Global… more
- Sanofi Group (Bridgewater, NJ)
- ** Global Medical Director , Early Pipeline Respiratory, Global Medical Immunology** **About Sanofi** At Sanofi, we are committed to the growth of our people, ... clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop… more
- Sanofi Group (Bridgewater, NJ)
- …clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop ... gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical Head of… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director , Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty Care...linked to business strategies + Partner closely with Public Affairs on development and execution of global … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …state community. This role works with the Clinical Development, Clinical Operations, Regulatory Affairs , Program Management, and teams.* Interfaces with both ... Description: We are seeking a Medical Director , Migraine and Cluster Headaches, to join our...Migraine and Cluster Headaches, to join our US Medical Affairs team at Amneal Pharmaceuticals, Inc. The role serves… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** + The Director ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more