Director/Senior Director, Regulatory Affairs

Role: Senior Regulatory Affairs leader responsible for establishing the regulatory function within HUTCHMED International, supporting global product registration strategies to secure US and EU approvals. Responsibilities: prepare and submit regulatory filings (INDs, NDAs, sNDAs), develop submission strategies and timelines, serve as primary US FDA contact, facilitate health authority meetings, and coordinate responses across global teams and CRO partners. Requirements: BS in a scientific or health discipline; advanced degree preferred (PhD, PharmD); 10+ years industry experience with a proven track record in US/EU filings and product approvals; strong knowledge of regulatory policies, GCP, ICH guidelines, drug development processes, and regulatory reform initiatives. Preferred: management experience, leadership, excellent communication skills. High-Value: focus on global registration, US/EU regulatory interactions, IND/NDA filings, health authority meeting facilitation. WorkSetup: not specified; likely office-based based on responsibilities.