- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …7 or More Years in the pharmaceutical industry preferred + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA preferred **Travel:** + Ability to ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… 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
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …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 (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)
- …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
- Integra LifeSciences (Princeton, NJ)
- …in the Marketing, Business Development, R&D/Process Technologies Clinical Operations, Strategy, Regulatory Affairs , Market Access, and other key functions, to ... and making headway to help improve outcomes. The Medical Director for the Surgical Reconstruction (SR) Franchise will be...regulations in the medical device industry. + Experience in global Medical Affairs or similar function and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and immune disorders. **Summary** With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC,… more
- J&J Family of Companies (Raritan, NJ)
- Sr. Director Medical Affairs TA Leader XTA - 2406217684W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare ... accountability for the delivery of the TA portfolio for Global Development (GD). The scope of the position includes...across multiple indications within a given TA. Within Medical Affairs Operations manages >60 internal budget owners at the… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Merck (Trenton, NJ)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Merck (Trenton, NJ)
- …position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility ... Japan, Australia and Brazil + Stay abreast of evolving global regulatory landscapes for medical device and...analysis of data for management review. **Reports to** - Director Regulatory Compliance, Device Quality and … more
- Bristol Myers Squibb (Princeton, NJ)
- …Lead , this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and ... integrate one global compliance program...Include : + Conduct risk assessments specific to medical affairs and clinical trial /research activities, utilizing a combination… more