- Medtronic (Minneapolis, MN)
- …Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards. + Effective negotiation ... submissions and reports for FDA or provide support and documentation for global submissions. + Maintain proficiency in worldwide regulatory requirements. Obtain… more
- ADM (Chicago, IL)
- …and new products versus regulation applicable in the region and liaise with global regulatory network for other regions. + Advise quality department for ... US regulation of food and/or dietary supplement ingredients or products. + Global Regulatory Affairs experience. + Leadership and team management experience.… more
- Organon & Co. (Jersey City, NJ)
- …regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation ... to assess acceptability and identify potential risks. Execute global regulatory strategies by leading the development, authoring and review of CMC submission… more
- Sumitomo Pharma (Frankfort, KY)
- …of **Senior Manager, Regulatory Affairs** . The Senior Manager is part of the Global Regulatory Affairs (GRA) team based in the US and he/she will primarily ... function as a regional regulatory leader (RRL) and support the global regulatory leader (GRL) as requested. This position is responsible for the preparation,… more
- Organon & Co. (Jersey City, NJ)
- …teams, along with alliance partners and commercial teams, in creating and implementing global regulatory CMC strategies for the registration, maintenance, and ... expansion of biosimilar products. + Lead the development and implementation of global regulatory strategies by assessing CMC changes, identifying regulatory… more
- Bausch Health (Bothell, WA)
- …product dossiers. **Cross-functional Collaboration** + Act as the key liaison between the global regulatory affairs team and other departments, such as R&D, ... marketing. ** Regulatory Intelligence and Reporting** + Stay informed about global regulatory trends and ensure the company is prepared for changes in… 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 + ... for CMC regulatory and CMC development + Keep current with global regulatory guidelines applicable to CMC + Perform other duties as assigned Basic… more
- Edwards Lifesciences (Irvine, CA)
- … strategic plans. + Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and ... II and/or Class III devices + Full knowledge and understanding of global regulatory requirements for new products or product changes. + Excellent written and… more
- IQVIA (Falls Church, VA)
- …COA dossier, briefing documents for Type B/C/D consultations) + An understanding of the global regulatory environment as it pertains to patient experience data + ... and/or business development purposes + Directly line manage a small global team of regulatory specialists + Mentor, coach, and share subject matter expertise… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …other duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... members of the team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to prioritize… more