Responsibilities
1. Plan, respond, and review regulatory requests and interactions, regulatory submissions, label updates, etc.
2. Contribute to the preparation, review, and approval of the product Investigator Brochures (IB), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Profile, and any other right-to-operate documents as required.
3. Interact and build relationships with external parties, including collaborators, investigators, clinicians, and thought leaders.