- Edwards Lifesciences (Irvine, CA)
- … strategic plans. Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements ... US FDA, EU notified bodies, Japan PMDA, Australia TGA, China NMPA other global regulatory agencies). + Monitor proposed and current global regulations and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …CMC Regulatory activities and initiatives + Deep understanding of global regulatory requirements and guidelines + Excellent communication and interpersonal ... guidance + Lead the preparation of risk assessments on major global CMC regulatory issues + Provides regulatory assessments for manufacturing changes and… more
- Lilly (Philadelphia, PA)
- …Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans + ... CMC regulatory assessment for change controls + Keep current with global regulatory guidelines applicable to CMC + Perform other duties as assigned. **Basic… more
- Applied Materials (Austin, TX)
- …timelines, and resource allocation. . Stay up to date with evolving global regulatory requirements and industry standards, ensuring compliance across all ... management principles and practices related to compliance. . Knowledge of global regulatory requirements, such as RoHS, REACH, WEEE, and other relevant product… more
- Applied Materials (Austin, TX)
- …timelines, and resource allocation. . Stay up to date with evolving global regulatory requirements and industry standards, ensuring compliance across all ... principles and practices related to compliance. . In-depth knowledge of global regulatory requirements, such as RoHS, REACH, WEEE, and other relevant product… more
- J&J Family of Companies (Raritan, NJ)
- … regulatory strategies. * Leading the North America discussions during the Global Regulatory Team and be a key contributor on multiple cross-functional ... other Health Authorities (HAs) if appropriate. * Developing a regulatory strategy that will deliver global and/or regional needs with initial focus on the key… more
- Grifols Shared Services North America, Inc (Columbia, SC)
- …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
- Abbott (Santa Clara, CA)
- …Tricuspid Heart Valve Repair Franchise. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, ... + Supporting pre-market and post-market cross functional teams; developing and communicating global regulatory strategies for new product submissions or complex… more
- Mastercard (New York, NY)
- …are building a sustainable world that unlocks priceless possibilities for all. Overview The Global Regulatory team is looking for a Senior Managing Counsel, ... their greatest potential._ **Title and Summary** Senior Managing Counsel, Regulatory Who is Mastercard? Mastercard is a global... Regulatory Who is Mastercard? Mastercard is a global technology company in the payments industry. Our mission… more
- AbbVie (North Chicago, IL)
- …& Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, ... data and strategy to regulatory agencies. + Responds to global regulatory information requests. + Develops strategies for CMC agency meetings, manages… more