- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …Director Clinical Development - Psychiatry Date: Jan 28, 2025 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... commercial, regulatory , pharmacovigilance, manufacturing, and pre-clinical development. The Senior Director will serve as a clinical leader for INDs, NDAs, BLAs,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Director Clinical Development - Respiratory Date: Jan 21, 2025 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more
- Sanofi Group (Morristown, 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
- Teva Pharmaceuticals (Parsippany, NJ)
- … Director , Patent - Parsippany, NJ Date: Jan 28, 2025 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 60468 **Who ... implementing IP strategies for our generic products in the US market. Reporting to the Senior Director ,..., Patent, you'll collaborate with cross-functional teams, including R&D, regulatory affairs , and portfolio management, to ensure… more
- Sanofi Group (Morristown, 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
- Teva Pharmaceuticals (Parsippany, NJ)
- HR Director , Data & Analytics Date: Jan 23, 2025 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 60294 **Who we ... to make a difference with. **The opportunity** The HR Director , Data & Analytics will drive data-driven decision-making across...Work closely with other departments, such as R&D and Regulatory Affairs , to align HR data initiatives… 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
- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …General Counsel, Market Access & Pricing Date: Jan 5, 2025 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 58778 ... to make a difference with. **The opportunity** The Senior Director , Associate General Counsel, Market Access and Pricing role...Pricing role reports directly to the SVP, General Counsel, US Commercial and TGO. This position is responsible for… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Associate General Counsel, Transactions Date: Jan 6, 2025 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 58194 ... their interdependent functions, including R&D, intellectual property, supply chain, finance, and regulatory affairs . This role will also help oversee internal… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to the terms and conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer, Gilead Sciences Inc. is committed ... areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities… more