- 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)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… 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)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...for operational matters. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project. Lead and… 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 ... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Bayer (Whippany, NJ)
- …and category knowledge to US Medical Strategy , Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical Affairs for ... 832367 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Compliance, Radiology, Regulatory Affairs , Clinical Research, Medical Research, Legal,… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. As a Senior Director in Health Economics and Outcomes Research (HEOR), you will be responsible for ... building top-notch HEOR capabilities and implementing an HEOR strategy that is integrated and aligned with Product Development Plans (PDPs) and Clinical Development… more
- J&J Family of Companies (Raritan, NJ)
- … regulatory strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy , commercial and market access ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can...GRL) and global regulations as they relate to overall regulatory strategy is preferred. + Ability to… more
- Sanofi Group (Bridgewater, NJ)
- **Position Title: - Director , Portfolio Marketing Strategy Lead - Portfolio Marketing** Location: Bridgewater and Morristown + 50% remote working and 10% of ... billion people worldwide per year. The Head of Portfolio Strategy will report to the Portfolio Marketing and Operations...Marketing teams, Sales teams across all channels, Medical, Public Affairs , Market Access, and Finance, as well as Global… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...of GLLs to ensure alignment of labeling content and strategy and to optimize resources + Department Coordination: Builds… 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 is ... millions of patients around the world. **Main** **Responsibilities:** The US Medical Director , Mainline Vaccines, will contribute to development and execution of the… 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** US Medical Director - Portfolio, New Products, Innovation- Vaccines **Location** : Bridgewater, NJ **About the Job:** The North American Medical Team ... millions of patients around the world. **Main Responsibilities:** The US Medical Director - New Products will provide medical and scientific guidance for the entire… 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 ... **Global Medical Director , Early Pipeline Respiratory, Global Medical Immunology** **About...development and execution of an integrated respiratory portfolio medical strategy . + Lead chronic obstructive pulmonary disease (COPD) medical… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide… 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 ... diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical Head of Immunology and… more