- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate 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… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the Medical Sr. Director , Strategy Lead of PAQ Virology. The Associate Director of Medical Affairs - PAQ Virology will support the US launch planning and ... diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our...PBC therapeutic area. + Identify and develop patient access strategy and research opportunities for US payers and key… more
- J&J Family of Companies (Raritan, NJ)
- Director , Regulatory Affairs -...are in alignment with product portfolio, regional strategies, CMC Regulatory Affairs strategy , commercial and ... 2406188412W **Description** **Employer:** Janssen Research & Development, LLC **Job Title:** Director , Regulatory Affairs **Job Code:** A011.5200 **Job… more
- J&J Family of Companies (Raritan, NJ)
- Director , Global Medical Affairs Strategy and Execution, Specialty Ophthalmology - 2406188956W **Description** Johnson and Johnson Family is recruiting a ** ... (GMAF) data generation and dissemination strategies and projects, as outlined below: The Director , Global Medical Affairs Strategy and Execution will be… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional...need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR...or More Years relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the clinical ... Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy /Portfolio Management, Global Device… 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)
- …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
- Novo Nordisk (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific resources, communications, and training initiatives for the medical affairs team + Serve on Clinical Trial Strategy… more
- Novo Nordisk (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific resources, communications, and training initiatives for the medical affairs team + Serve on Clinical Trial Strategy… more
- Stryker (Allendale, NJ)
- …Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... at www.stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our **Spine...purchasing groups, etc.) + Assists in the development of regulatory strategy and updates strategy … more
- AbbVie (Florham Park, NJ)
- …scientific, strategic and operational leadership and expertise into core medical affairs activities such as: generation of clinical and scientific data) (enhancing ... and benefit/risk. Works closely with cross-functional medical partners to support medical affairs activities that advance the appropriate and safe use of our… more
- IFF (Hazlet, NJ)
- …scent design managers, account teams and customers. This role will be reporting to the Director of Regulatory Affairs , Americas. About You: To be successful ... Manager, Regulatory Affairs - North America (Hybrid) Apply...sustainability and product claims. + Articulate and execute GRA strategy by giving internal and external presentations. + Actively… more
- New York State Energy Research and Development Aut (New York, NY)
- …and renewable energy. Job Overview The Vice President, Legal and Regulatory Affairs will report directly to NYGB's Managing Director , Legal and Regulatory ... LOIs + Working with NYGB senior management and its Strategy and Communications team to manage applications for federal...firms; and + Consulting and collaborating with NYGB's Managing Director , Legal and Regulatory Affairs … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …level, while also seeking their input and feedback to inform state government affairs strategy and engagement. Contributes to internal and external advocacy and ... and immune disorders. **Summary** With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states… more