Senior Director, Global Regulatory Affairs – Biotech Unit

Role: Regulatory Affairs Lead focusing on global regulatory strategy development and oversight for oncology development programs. Responsibilities: provide strategic and operational regulatory guidance across all development phases; manage IND/CTA, NDA/MAA submissions; liaise with global health authorities; oversee regulatory compliance and risk assessments; support clinical study planning and execution; mentor teams, and advise on policy and regulatory environment changes. Requirements: Bachelor's degree (advanced degree preferred), 12+ years in biopharma, with at least 5 years in regulatory leadership, especially in oncology; extensive experience with INDs/CTAs, NDAs/MAAs, and regulatory agency interactions; strong strategic, leadership, and cross-functional collaboration skills; fluent in English, Mandarin desirable. HighValue: oncology, global regulatory strategy, IND/CTA/NDA/MAA submissions, multi-geographic experience (US, China, EU), lifecycle management, regulatory agency negotiations. WorkSetup: individual contributor role, up to 20% domestic/international travel.