- 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 + Experience in … 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
- J&J Family of Companies (Titusville, 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where...community we serve. Position Summary: Under the leadership of Regulatory Affairs the incumbent manages global… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for ... 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
- 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
- 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
- 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
- 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
- J&J Family of Companies (Skillman, NJ)
- …Associate, Regulatory Affairs , Dietary Supplements This position reports to the Director , Regulatory Affairs and is based in Skillman. **Who we are** ... Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue...Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse… 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …and company objectives. + Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead ... MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements**… more
- Ascendis Pharma (Princeton, NJ)
- …and services are fully compliant with Ascendis SOPs and US as well as global regulatory and compliance rules/law. Requirements . MD or MD/PhD or equivalent ... Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… 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
- 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