- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. + Gain endorsement from ... product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… 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
- Merck (Rahway, NJ)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...regulatory strategy for their assigned products, in order to optimize… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Director , Regulatory Affairs , Specimen Management reports directly to the VP Regulatory Affairs , Specimen Management. ... This position is responsible for the Specimen Management Regulatory Affairs operations and strategy ...registrations, sustaining support, and regulatory advocacy. The Director , Regulatory Affairs , Specimen Management… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with… more
- Merck (Rahway, NJ)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- New York State Energy Research and Development Aut (New York, NY)
- …senior attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... for overseeing and being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the highest level of industry… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs . The incumbent will lead a group ... regulatory strategies for product development. This management position in Regulatory Affairs involves the ability to lead and manage a Therapeutic Area (TA)… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … strategy . + Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on cross-functional/cross-regional sub-teams ... TA. You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional ...Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion… 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
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... performance against metric targets. + Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own. + Lead… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... be determined by the qualifications listed below. The Medical/Scientific Director , Medical Affairs - Psychiatry Pipeline is...compliance with regulatory and ethical standards in all medical … more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director ... the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Director , Medical Affairs Oncology Digital & AI Innovation will report to the Oncology AI Innovation Head. This is a vital role within the ... and transform cancer patients' outcomes. **DIGITAL RESPONSIBILITIES** + Lead Digital solution strategy for Oncology medical affairs . + Optimize budget spend,… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Haemophilia Medical Director , Rare Disease Global Medical Affairs , is an integral member of the therapeutic area focused team. The ... and exhibit customer-focused medical professionalism with honor and integrity. The medical director reports to the Global Medical Affairs Lead, Hemophilia.… more
- AbbVie (Florham Park, NJ)
- …Contributes to the development of brand strategies. + Lead and support Medical Affairs initiatives ( strategy and tactics) for Parkinson's Disease asset launch + ... Park, NJ preferred. Will consider remote candidates. Purpose: The Scientific Director provides medical and scientific strategic and operational input into core… more