- 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...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… 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 ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior ... Director of Regulatory Affairs / Clinical Affairs in...Audits conducted by the CRA ANDA Department within the US and International. + Submission/tracking of inter department communications… more
- Bausch Health (Bridgewater, NJ)
- …international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek ... embody these values, come join our company and help us shape the future. We are all in it...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)
- … strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access strategy, and ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …We are seeking a Medical Director , Migraine and Cluster Headaches, to join our US Medical Affairs team at Amneal Pharmaceuticals, Inc. The role serves as the ... state community. This role works with the Clinical Development, Clinical Operations, Regulatory Affairs , Program Management, and teams.* Interfaces with both… more
- J&J Family of Companies (Raritan, NJ)
- …and benefits information set forth in this posting applies to candidates hired in the United States . Candidates hired outside the United States will ... Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Oncology (Solid Tumor) to...Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US , the EU and… more
- Sanofi Group (Bridgewater, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job Title:** Medical Director - Global Medical Evidence Generation **Location:** Cambridge, MA **About the Job** We are an innovative global healthcare company,… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** US Medical Director - Portfolio, New Products, Innovation- Vaccines **Location** : Bridgewater, NJ **About the Job:** The North American Medical ... real impact on millions of patients around the world. **Main Responsibilities:** The US Medical Director - New Products will provide medical and scientific… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** US Medical Director , Mainline Vaccines **Location** : Bridgewater, NJ / Morristown, NJ **About the Job** The North American Medical Team at Sanofi ... millions of patients around the world. **Main** **Responsibilities:** The US Medical Director , Mainline Vaccines, will contribute...information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …industry experience required + 4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience required + Experience ... pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience + Experience with ex-… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title** : Global Director of Communications for Hemophilia **Location:** Cambridge, MA **About the Job** Sanofi is seeking a strategic, motivated, and ... experienced communications professional for the position of Global Director of Communications for Hemophilia, part of the Rare Diseases Franchise. This position will… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Associate Director , Consumer Marketing - US Rare Hematology **Location** : Cambridge, MA **_About the Job_** This role will drive consumer ... disorder. This position is based in Cambridge, MA and will report into Director of Consumer marketing for rare hematology. We are an innovative global healthcare… more
- Sanofi Group (Bridgewater, NJ)
- …into the Global Medical Immunology team that is part of the Medical Affairs Specialty Care organization. Our Medical function serves as a key strategic partner ... with commercial, regulatory , clinical, and market access on therapeutic solutions to...solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …industry experience required + 4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience required + Experience ... immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to...applicable, partner companies for the development and approval of US , EU and global CCDS documents for regulatory… more