- 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, ... potential. At Johnson & Johnson, we all belong. The Director , Global Regulatory Leader... / North American/ regulatory strategies. + Lead the Global Regulatory Team… more
- Novo Nordisk (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal stakeholders and external CRO ... to the best of my knowledge. **Job Description** The Regulatory Affairs-Labeling, Associate Director is responsible for...partners such as Global Regulatory Compliance, Global Labeling,… more
- Bristol Myers Squibb (Princeton, NJ)
- …through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute ... and Health Authorities. Develop & communicate strategic direction based on global regulatory guidelines and experience. **Position Responsibilities** In addition… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … regulatory strategy is endorsed by GPT and other governance bodies. + Serve as a leader of the GRT ( Global Regulatory Team) + The primary point of ... and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects....or More Years of proven experience in a regional regulatory lead role + 7 or More… 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...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Sumitomo Pharma (Trenton, NJ)
- …with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected to provide regulatory ... The Associate Director is part of the Global Regulatory Affairs (GRA) team based in...the candidate's skill-set, may also be assigned as a Global Regulatory Leader (GRL) with… more
- Sumitomo Pharma (Trenton, NJ)
- …will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is ... ** Director Regulatory Affairs** . The Director is part of the Global ... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution. + Participate in ... for operational matters. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project. Lead and...global product team meetings to provide US … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Nestle (Bridgewater, NJ)
- …supplement brands, and pharmaceutical therapies, we are redefining the management of health. The Global Marketing Lead / Director , Solgar will lead the ... **Position summary** Nestle Health Science is a globally recognized leader in the science of nutrition, with more than...diverse context. **A day in the life of a Global Marketing Lead / Director , Solgar** +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Taiho Oncology (Princeton, NJ)
- …be assigned to lead /support one or two clinical development programs as Regulatory Lead (RL), responsible for regulatory strategy and execution ... Associate Director , Regulatory Affairs Strategy Princeton, NJ,... affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides … more
- Merck (Trenton, NJ)
- … CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and ... **Job Description** The Executive Director , Device Quality & Regulatory will... regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and… 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 ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Sanofi Group (Bridgewater, NJ)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... Immunology pipeline assets. The Medical Director will report directly to Global Medical Evidence Generation Lead , Next-Gen Immunology Franchise and will be… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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… more
- Sanofi Group (Bridgewater, NJ)
- ** Global Medical Director , Early Pipeline Respiratory, Global Medical Immunology** **About Sanofi** At Sanofi, we are committed to the growth of our people, ... world. **Job Responsibilities:** + The Early Pipeline Respiratory Medical Director reports to the Global Medical Head...direction of the Global Respiratory and Gastroenterology Global Medical Lead + This role will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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… more