Director, Regulatory Affairs for GE HealthCare Products
GE HealthCare
Take charge as Director of Regulatory Affairs with GE HealthCare, focusing on the Pharmaceutical Diagnostics portfolio. Drive regulatory initiatives for new product development and ensure compliance across major markets. Reporting to the Head of Regulatory Affairs, you will be essential in orchestrating regulatory strategies and lifecycle management of marketed products. This role emphasizes collaborative efforts with R&D, Quality, and Clinical teams to ensure timely regulatory submissions and approvals. Key Responsibilities:
- Lead the development of regulatory approval strategies
- Provide insights for fast-tracking product development
- Handle submission inquiries and documentation preparation
- Coordinate regulatory meetings and briefings
- Ensure compliance with FDA and Health Canada guidelines
- Bachelor’s in Life Sciences; advanced degree preferred
- At least 5 years in regulatory affairs with a track record
- Expertise in IND processes and lifecycle management
- Proficient in FDA and Health Canada negotiations
- Relevant background in sterile injectables preferred
Vacancy posted 6 days ago
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