- 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
- 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
- J&J Family of Companies (Trenton, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located ... Director , Global Regulatory Leader...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus 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 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
- 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
- Taiho Oncology (Princeton, NJ)
- …Commercial Organization and other product-related teams. Foster and facilitate communication with Global Regulatory Affairs on these topics, including ... Associate Director , Regulatory Affairs Strategy...Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA...of the Global Project Team to represent Regulatory Affairs for assigned projects/products. + Advise… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** **Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory ... may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing… more
- Merck (Trenton, NJ)
- **Job Description** ** Global Senior Director of Medical Affairs for Thoracic Malignancies** + The Global Senior Director of Medical Affairs ... (GDMA) for Thoracic Malignancies coordinates the development of the Global Scientific and Medical Affairs Plans for their assigned asset(s). + The GDMA… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... for the United States and the Americas and supporting global needs as required. The RA Associate Director...for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging… more
- J&J Family of Companies (Raritan, NJ)
- Senior Director , Head of Global Medical Affairs for Pulmonary Hypertension - 2406190815W **Description** Johnson and Johnson Family is recruiting a **Senior ... Director , Head of Global Medical ...+ Strong understanding of the clinical development activities and global regulatory requirements + Good understanding of… 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 ** ... and dissemination strategies and projects, as outlined below: The Director , Global Medical Affairs Strategy...frequent interactions with global and regional medicals affairs , commercial and market access colleagues, R&D, regulatory… 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 (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)
- …around rare diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, ... side) + **CDx RA Policy and Intelligence:** Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these… 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
- 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