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Check out JobsAI Manager, Regulatory Affairs
Company Name: ADMA Biologics, Inc.
Job Overview
The Manager, Regulatory Affairs supervises the planning, preparation, and evaluation of regulatory documents for submission to the FDA. They serve as a regulatory resource for internal teams, offering guidance on FDA inquiries for both investigational and marketed products. The manager ensures adherence to regulatory requirements and provides timely guidance across company functions, maintaining contact with the Associate Director of Regulatory Affairs.
Responsibilities
- Preparing and reviewing regulatory submissions
- Assessing document accuracy
- Determining regulatory strategies aligned with business objectives