- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you ... regulations. You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the… more
- Merck (Rahway, NJ)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in...possible. Ready to get started? **Main responsibilities:** + Represents Global Regulatory Affairs (US RA… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- … compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs . The person will be responsible ... it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory guidance to ... and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… 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 ... products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in...Affairs will stay abreast of changes in the global /US/Canadian regulatory framework, analyze proposed legislation/guidance that… 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 (Early Development), may be ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… more
- Merck (Rahway, NJ)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... and external regulatory agencies. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and… more
- Bausch Health (Bridgewater, NJ)
- …and regulatory agency guidance. Responsibilities: + Manages or represents Regulatory Affairs on the promotional review committees for prescription products ... Bausch Health is a global company that develops, manufactures, and markets a...new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review… more
- New York State Energy Research and Development Aut (New York, NY)
- …passion to work in a fast-paced environment on the cutting edge of energy policy. The Director , Legal and Regulatory Affairs will report directly to the NY ... York is leading the nation in the fight on global climate change and the transition to a clean...Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Bausch Health is a global company that develops, manufactures, and markets a...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- 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)
- …or More Years in the pharmaceutical industry required. + 7 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device ... aspects of registration activities with a working knowledge of regulatory affairs , in the development of the...effectively in a multidisciplinary team. + Experience working with global regulatory agencies. + Demonstrated business acumen… more