- Sumitomo Pharma (Trenton, NJ)
- … strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply… 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 ... while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing,… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well ... or regions of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Roche (Branchburg, NJ)
- …across the diagnostics value chain ensuring our right to operate, shaping the global regulatory environment, and accelerating access to our diagnostic solutions ... Position** **2026 Summer Intern - Roche Diagnostics Quality & Regulatory Affairs** **Department Summary** As a global ...& Regulatory Affairs** **Department Summary** As a global leader in healthcare, Roche Diagnostics offers a broad… more
- J&J Family of Companies (New Brunswick, NJ)
- …at https://www.jnj.com/medtech This Senior Counsel position is for an attorney within the Global Regulatory Legal Team of the GLO. The responsibilities of this ... and Johnson & Johnson policy teams. + Being a member of the Global Regulatory Legal Team and collaborating with GLO colleagues around the world. + Partnering… more
- Bausch + Lomb (Trenton, NJ)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication ... Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …establish Regulatory Requirements. + Support development and execution of global regulatory strategies by collaborating closely with international ... regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other global regulatory agencies and experience negotiating with regulatory authority personnel… more
- Sumitomo Pharma (Trenton, NJ)
- …**Director, Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...function as the Regulatory reviewer for assigned products. This position is responsible… more
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