Plans and leads health authority interactions, including pre-IND, INTERACT, Type A/B/C, End-of-Phase 2, and pre-BLA meetings, EMA scientific advice, and PMDA consultations; directs briefing document strategy and preparation, prepares project teams, and serves as a primary company contact with FDA (CBER/OTP), EMA, and other agencies. Leads regulatory strategy for, and oversees preparation of, major submissions, including INDs/CTAs and amendments, annual reports, DSURs, orphan and expedited program designation requests, pediatric plans (iPSP/PIP), and BLA/MAA, ensuring filings are accurate, high quality, and submitted on time.