- 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 ... the 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
- 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
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in… more
- J&J Family of Companies (New Brunswick, NJ)
- Director , Regulatory Affairs (WCH & Biosurgery) - MedTech Surgery, Inc. - 2406219356W **Description** **MedTech Surgery** , part of Johnson & Johnson, is ... recruiting for a ** Director , Regulatory Affairs ** to support...the US). This role can also support combination product strategy (ie, biologics/medical device, medical devices with a medicinal… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Merck (Rahway, NJ)
- …We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... priorities. **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development and implementation… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the preparation, review, and submission of documents for FDA, ... for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams 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
- 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
- Bayer (Whippany, NJ)
- …and category knowledge to US Medical Strategy , Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical Affairs for ... to make a real difference, there's only one choice.** ** Director Medical Affairs US Radiology (Breast)** The...press releases; + S/He will contribute to post approval regulatory required trials by the FDA. This position will… 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)
- …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
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Compliance & Ethics, Global R&D and Medical Affairs Date: Nov 3, 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)
- …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)
- …Medical Affairs Communications Oncology** The Director , Medical Affairs Communications Oncology manages strategy and implementation surrounding the ... well as executives in Marketing, Sales, Manufacturing, Drug Safety, Quality Assurance, Regulatory Affairs and Legal Departments; + The incumbent participates… more