- 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
- Insight Global (Basking Ridge, NJ)
- …Time Zone is preferred but not required. Responsibilities: Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA ... 10+ years in the pharmaceutical industry. 8+ years in regulatory affairs . Experience in providing regulatory...processes. In depth knowledge of oncology and associated RA strategy Experience acting as primary point of contact with… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... 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
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… 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
- 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
- City of New York (New York, NY)
- … Director of OCMH and executive staff to set and execute the External Affairs strategy for the office. Additionally, the Deputy Executive Director will ... Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the...by directing and supporting the development of OCMH's media strategy to ensure clear and compelling updates to the… 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
- ABM Industries (New York, NY)
- **Overview** ABM Industries seeks a dynamic and experienced ** Director of Sustainability and Government Affairs ** to lead and manage the company's sustainability ... environmental, social, and governance objectives while ensuring alignment with regulatory frameworks and advocating for favorable government policies. The ideal… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Corporate Affairs - Brand Communications Date: Jan 10, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job ... people to make a difference with. **The opportunity** The Director , Corporate Affairs - Brand Communications at...therapeutic areas in alignment with our Pivot to Growth strategy , for media, investors, employees, and other audiences. The… more
- Novo Nordisk (Plainsboro, NJ)
- …key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy & Marketing, and the ... lives for a living. Are you ready to make a difference? The Position The Strategy Director is a senior individual contributor role, and the job function requires… 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
- Novo Nordisk (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required + A thorough understanding ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson is recruiting for a Senior Director , CAR-T Global Marketing and Commercial Strategy located in Raritan, NJ. At Johnson & Johnson, we believe ... profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Senior Director , CAR-T Global Marketing and Commercial Strategy will report… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Director of Trade and Market Access Strategy is a pivotal member of ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more