- 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)
- …+ 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)
- …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)
- …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
- AbbVie (Florham Park, NJ)
- …YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for setting strategy and leading ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- J&J Family of Companies (Union, NJ)
- …RA Dietary Supplements - 2407024953W **Description** Kenvue is currently recruiting for: Director , Regulatory Affairs , Dietary Supplements This position ... reports to the Senior Director , Regulatory Affairs and is...Regulatory Affairs is responsible for developing regulatory strategy and providing guidance to product… 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
- 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
- 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy . + Knowledge of CMC regulatory ... database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development,… 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
- 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
- AbbVie (Florham Park, NJ)
- …statistics, regulatory , etc) as they relate to on-going medical affairs projects. May assist as consultant/liaison with other corporations when working under ... discovery, statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison with other corporations when… 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
- AbbVie (Florham Park, NJ)
- …can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and ... scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Compliance & Ethics, Global R&D and Medical Affairs Date: Sep 6, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... **The opportunity** The Director Compliance & Ethics, Global R&D and Medical Affairs reports to the Global R&D Compliance Officer, with a dotted line reporting… 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