- Evident Scientific (Needham, MA)
- …of US products and processes. **Cross-Functional & Global Collaboration** + Lead coordination between Clinical Affairs, US regulatory operations, and ... Regulatory Affairs (US Focus)** + Act as US regulatory lead for clinical and medical device...during inspections and submissions. **Clinical Study Program Leadership** + Lead global clinical studies from concept to… more
- Medtronic (Minneapolis, MN)
- …Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to ... and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies. + **Knowledge of Regulatory Requirements:** In-depth… 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
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and ... reports directly to the Rare Disease Medical Business Unit (BU) Lead . **Job Description** **Key Responsibilities Include:** **Medical Strategy & Narrative** +… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Service Delivery Lead - Global MES Manufacturing and Quality** **Help us advance our purpose ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...(MES) Team is actively looking for a Service Delivery Lead to drive operational excellence in service delivery across… more
- RELX INC (Dayton, OH)
- …with 11,800 employees worldwide, is part of RELX (https://www.relx.com/) , a global provider of information-based analytics and decision tools for professional and ... case. About the Role We are looking for an innovative AI Content Optimization Lead to drive AI ideation and workflow integration in Practical Guidance content within… more
- Takeda Pharmaceuticals (Lexington, MA)
- … CMC project teams for complex biologic products and guide CMC teams with the CMC lead . + Lead Global Technology Transfer Projects + Ensure timely execution ... **Job Description** **About the role** Join us as our **CMC Sr. Project Lead ** , **_Global Biologics Manufacturing Sciences_** _(GMsci Bio)_ and play a pivotal role… more
- Takeda Pharmaceuticals (Boston, MA)
- …with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. + Ensure site compliance with global ... on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent … more
- 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 ... ensures that they conform to current GMP and meet global regulatory requirements. The incumbent may participate...well in a team environment and the ability to lead others. + Working knowledge of project management. +… 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