Associate Regulatory Affairs Strategy Director (Oncology)

Lead the development and implementation of global regulatory strategies for oncology assets, ensuring timely, compliant submissions (e.g., INDs, NDAs, BLAs, CTAs) and effective communication with health authorities. Drive regulatory intelligence, risk assessments, and cross-functional guidance to asset and study teams; coordinate with external vendors for multi-regional submissions; review clinical trial documents for regulatory alignment; oversee preparation of regulatory submissions and internal SOPs; manage multiple assets/studies and liaise with internal departments and external partners to mitigate regulatory risk.