- 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
- Danaher Corporation (Port Washington, NY)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping… 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
- 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
- Merck (Rahway, NJ)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... Support device design control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products,… 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)
- …role, a typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the ... The candidate will be responsible for assuring development and execution of global regulatory strategies for assigned cell and gene therapy portfolios.… more
- Bristol Myers Squibb (Madison, 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
- The Coca-Cola Company (Whitestone, NY)
- …food science or relevant science discipline required. **Job Description Summary** : The Director , Scientific and Regulatory Affairs Compliance and Innovation ... develops, improves, and drives compliance to all Regulatory requirements at BODYARMOR. In addition, this role also...serve while delivering safe & quality products **.** + ** Global Connections:** Allows you to develop, enhance and maintain… 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. + 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs , Global Patient Safety, and Development Quality (RA, GPS and DQ), the ... Director will be responsible for functional area support. **In...values of the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs , Global Patient Safety,… 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
- IQVIA (Parsippany, NJ)
- …regulatory document types; * May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications; * May be assigned ... standard operating porcedures owned by other operations; * May support global regulatory or technical initiatives or act as a regional representative on… 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
- AbbVie (Florham Park, NJ)
- …understanding of relevant therapeutic area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred. + ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… 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