li>Responsible for the preparation, review, presentation, and publishing of all FDA submissions to assure accuracy and completeness of submission documents, which includes but is not limited to meeting requests/briefing packages and presentations to the FDA (e.g., preIND/pre-BLA, end-of-phase II, Type A,B or C, and advisory committee meetings), Investigational New Drug Applications (INDs), Biologic License Applications (BLAs), Orphan Drug Applications, Marketing and Promotional Materials, Product Listing and Establishment License Applications, and other related documents or CMC supplement submissions. Essential Functions and Responsibilities:
- Provides accurate and timely regulatory guidance to Management, Process Development, Analytical Development, Manufacturing, and the Quality Assurance/Quality Control staff while maintaining frequent contact with the Head of Regulatory Affairs.