Senior Manager, Regulatory Affairs
Company Summary:
My client, a leading CDMO working with biotechnology and pharmaceutical clients of all sizes to deliver life-changing and innovative therapies is looking to add a Senior Manager of Regulatory Affairs to the team! This rapidly growing company is in the midst of building a brand-new facility adjacent to their current facility and is planning to double their headcount! This role will be located onsite in Nashville, TN.
The Regulatory Affairs Senior Manager will be responsible for:
- Directing regulatory projects and providing strategic input to customers for regulatory submissions
- Managing correspondence with domestic/international regulatory agencies and managing annual reports
- Serving as regulatory representative on assigned projects and interacting with other departments to ensure achievement of common goals
- Acting as the key internal leader and driver of regulatory strategy and policy to provide executive management with regulatory measurements and advice
The Regulatory Affairs Senior Manager should have the following qualifications:
- Bachelor's degree and 5+ years of leadership/management experience in the pharmaceutical industry
- Strong knowledge of cGMPs and other global regulations
- Experience with computerized systems
