- Merck (Rahway, NJ)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global ... business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process… 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
- Taiho Oncology (Princeton, NJ)
- … regulatory affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory ... Associate Director , Regulatory Affairs Strategy...Performance Objectives: + Independently directs as well as prepares global regulatory affairs strategies and… more
- Insight Global (Basking Ridge, NJ)
- …. Skills and Requirements 10+ years in the pharmaceutical industry. 8+ years in regulatory affairs . Experience in providing regulatory strategic input into ... 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)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned...resolution. + Participate in global product team meetings to provide US … more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + 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. + 8 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)
- …+ 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 ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- City of New York (New York, NY)
- …Mayor's Office of Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the multidisciplinary External Affairs ... Director of OCMH and will directly manage 4 staff members.The Deputy Executive Director , External Affairs will work closely with the Executive Director … more
- Abbott (Princeton, NJ)
- …executives, and scientists. **What You'll Work On** + Reporting directly to the Sr. Director , Global Medical & Scientific Affairs (GMSA), Abbott Point of ... + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global Marketing &...established by the APOC Leadership Team + Supporting the Director of Global Scientific Affairs ,… more
- Merck (Rahway, NJ)
- **Job Description** **Job Scope** The Director , Corporate Affairs and Patient Innovation & Engagement Compliance has global compliance responsibility for all ... areas of Corporate Affairs , including Global Communications, Global and Regional Public Policy,...Research and Development Division's Value & Implementation organization. The Director serves as a dedicated global business… more
- Taiho Oncology (Princeton, NJ)
- …Taiho such as: Clinical Development, Commercial, HEOR, Market Access and Regulatory Affairs , Patient Advocacy, TOE, TPC and global teams to ensure as needed ... Medical Director , Medical Affairs Princeton, NJ, USA...we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.… more
- Bristol Myers Squibb (Madison, NJ)
- …**Key Responsibilities** + Strategic and Tactical Planning: Responsible for the US Medical Affairs plans, in coordination with the Global Medical Affairs ... 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… 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
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can be located in Spring House, PA; Horsham, PA; ... potential. At Johnson & Johnson, we all belong. The Director , Global Regulatory Leader, is...strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access… more
- Mondelez International (East Hanover, NJ)
- …within the North America and Global CGA team. This role reports to the Director , US Government Affairs , Mondelēz International. The role will be based in one ... Lead the Future of Snacking. Make It Matter.** The Senior Manager, US Government Affairs will have responsibility for leading state government affairs as part of… more