- Taiho Oncology (Princeton, NJ)
- …enhance your skills. Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho ... etc. and ensures that they conform to current GMP and meet global regulatory requirements. The incumbent may participate in interactions and negotiations with … more
- Ascendis Pharma (Palo Alto, CA)
- …their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global ... regulatory submissions across the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you will be responsible for contributing to the vision,… more
- Gilead Sciences, Inc. (Washington, DC)
- …together. **Job Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with ... development and regulatory path for combination products and devices. . ** Global Regulatory Excellence** Lead the development of global CMC regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Duties** + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health ... markets, such as North America, EMEA, Japan, and China. + Experience defining global regulatory strategies for digital health solutions in collaboration with… more
- Sumitomo Pharma (Lincoln, NE)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation,… more
- Reckitt (Parsippany, NJ)
- …and allow you to grow in our great organisation. **About the role** + Lead Global Regulatory & Safety (RAS) strategy for the Specialty & Allergy category and ... global and local teams. **Your responsibilities** + Develop and implement global regulatory strategies for innovation projects in Specialty & Allergy. +… more
- Kemin Industries (Des Moines, IA)
- …for Kemin products deemed necessary to achieve business outcomes such as global regulatory approvals and clearance for Kemin Health ingredients, labels, ... will provide guidance throughout all stages of innovation and commercialization, support global customers on regulatory and quality-related matters, and ensure… more
- Parexel (Pierre, SD)
- … global markets? Parexel is seeking an experienced and highly motivated ** Global Regulatory Labeling Lead** to provide strategic leadership and operational ... + Align labeling content and strategy across US, EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership.… more
- Parexel (Des Moines, IA)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... 5 years of biotech/pharma industry experience, including 2+ years in labeling/ regulatory operations with global responsibility. * Experience leading teams… more
- Medtronic (Minneapolis, MN)
- …Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to ... regulatory filings to the FDA, EU MDR, and other global regulatory agencies. + **Knowledge of Regulatory Requirements:** In-depth understanding of… more