- 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
- 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
- Merck (Rahway, NJ)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with...+ Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that… 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
- Merck (Rahway, NJ)
- **Job Description** The GRACS Global Process Model Lead is primarily accountable and responsible for the overall governance and leadership of the GRACS Global ... Business Process Model, including managerial responsibilities for the GRACS Global Process Leads, leadership for the Global Process Lead Network, as well as… 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
- Sanofi Group (Bridgewater, NJ)
- …focus preferred, but not required + Experience within pharmaceutical or medical device Regulatory Affairs + Successful track record with ideally 8-10 years ... **About the Job** We are an innovative global healthcare company with one purpose: to chase...meet internal and external customer needs. Develops and implements regulatory strategies for marketed products within their product area.… more
- J&J Family of Companies (Raritan, NJ)
- …recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs , supporting programs in the Immunology Therapeutic ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be...strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Development, may be called upon to ... 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) 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
- 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
- Merck (Rahway, NJ)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical...someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is… 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)
- …CAPAs. **KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on ... drive our collective progress and impact. **OBJECTIVES/** **PURPOSE OF JOB:** The Senior Director of Global Regulatory Operations is responsible for… 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 ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...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
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **i-hybriPosition Responsibilities** + Leadership responsibility for global regulatory strategy to support the development ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- 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)
- …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