- 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
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Medical Affairs Women's Healthcare** The Director US Medical ... based Candidate. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Medical Affairs Women's Healthcare, are to: + Active… 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
- 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
- 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
- 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
- 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