- 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
- Insight Global (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... Eastern Time Zone is preferred but not required. Responsibilities: Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for… 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
- 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
- J&J Family of Companies (Raritan, NJ)
- …of Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in ... regulatory affairs , submission management, or a related...in this posting applies to candidates hired in the United States . Candidates hired outside the … 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
- J&J Family of Companies (Raritan, NJ)
- …assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global ... responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations with...in this posting applies to candidates hired in the United States . Candidates hired outside the … 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** : Director Field Reimbursement Manager - East **Location:** Remote/Field **About the Job** The Sanofi Patient Support Services (PSS) team is focused on ... education and support to patients and customers. In this field-based position, the Director Field Reimbursement Manager - East reports to the Head, PSS Neurology… 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)
- …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
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Associate Director , Solutions and Industry Partnerships -Vaccines **Location:** Remote **About the Job** As the Associate Director , Solutions & ... designed for specific partnership channels + Work closely with HS Solutions, Public Affairs , HIT Solutions, Brand Marketing, and Market Access to ensure content both… more