- 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
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- AbbVie (Florham Park, NJ)
- …medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation ... input into core brand (product) strategies, and to support medical affairs , marketing activities (promotional material generation and product launches) and market… more
- AbbVie (Florham Park, NJ)
- …Development and Pipeline cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Reviews, assesses and reports ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical, Multiple Myeloma will report to the Director , ... medical support for a novel CELMoD asset and support for the asset medical strategy and book of work. This individual will be involved in executing an integrated… more
- AbbVie (Florham Park, NJ)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into core… more
- Bristol Myers Squibb (Madison, NJ)
- …Medical Neuropsychiatry Lead is responsible for developing and executing the medical affairs strategy across markets. This position will be responsible for ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Senior Director , WW Medical Neuropsychiatry Strategy ** **Location: Princeton Pike… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …your best self. Become a **maker** **of possible** with us. As the Medical Affairs Director of Innovation you will be responsible for leading efforts related ... and RWE Medical Affairs teams to support data analyses related to strategy assessment + Collaborate closely to relay findings to new product development teams… more
- Bristol Myers Squibb (Madison, NJ)
- …US and WW Commercial, Research and Development, Global Drug Development, HEOR, Regulatory Affairs , and other global medical stakeholders. This position reports ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Associate Director , WW Medical Neuropsychiatry Strategy , Schizophrenia** **Location:… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + Interact ... **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring...in development at BD while informing the broader scientific strategy with Medical Affairs . This role is… 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 (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
- 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