- 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)
- …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
- Catalent Pharma Solutions (Hillside, NJ)
- …Catalent employee. The primary duty of the **Associate Director , Regulatory Affairs ** is to support regulatory strategy for product development and ... **Associate Director , Regulatory Affairs ** **Position...in conjunction with clients in support of meetings with regulatory authorities + Provide regulatory strategy… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... and execution of the post-approval regulatory strategy , post-marketing commitments,post-marketing development and maintenance,...products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in… more
- Merck (Rahway, NJ)
- **Job Description** The Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for ... the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more of our Company's… 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
- Catholic Health Services (Roslyn, NY)
- …their credentials. Job Details The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible ... and aligning operational and financial results Identifying and communicating regulatory requirements Developing the strategy for the implementation… 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)
- …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
- 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
- Novo Nordisk (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents for inclusion in these applications + Review of regulatory strategy documents; eg, provides supervisor with… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As an Associate Director , Strategic Business Planning & Execution you will provide strategic & operational project management excellence to our Immunology & ... Inflammation Global Medical Affairs Therapeutic Area Heads & Medical Directors. We work...ability to collaborate with the commercial/marketing organization ensuring our strategy , plan & execution follow medical input & direction… more
- Bausch Health (Bridgewater, NJ)
- …and effective aesthetic care options to consumers and physicians alike. The Professional Affairs lead is accountable for the designing & executing Solta's education ... strategy , developing & nurturing relationships with internal & external...collaboration and teamwork with key partners such as, Medical Affairs , Marketing, Sales, Compliance, Quality, KOLs, etc. This role… more
- Merck (Rahway, NJ)
- **Job Description** As a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical ... role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within Medical… more
- Colgate-Palmolive (New York, NY)
- …then give your career a reason to smile and join our global team! The Director of North America (NA) Consumer Care & Experience (CCE) Operations at Colgate Palmolive ... consumer/customer service that meets corporate and local standards with regulatory compliance, cost efficiency, and achievement of key performance indicators… more
- AbbVie (Branchburg, NJ)
- …Purpose: Responsible for the development and implementation of global regulatory strategy and representation of Regulatory Affairs on R&D project ... Director ), in the development and execution of the regulatory strategy . Assigned matters may have a...lieu of, plus at least 4 years' experience in Regulatory Affairs ; or . Education equivalent to… more