Associate Director, GRS Heme/Onc

Role: Associate Director, GRS Heme/Onc, responsible for developing global regulatory strategies for hematology and oncology therapeutics throughout development and lifecycle management. Responsibilities include leading regulatory dossier submissions (INDs, BLAs, NDAs, supplements), ensuring compliance and quality controls, collaborating with cross-functional teams on submission contributions, and managing interactions with health authorities such as the FDA. The role involves leading regional regulatory sub-teams, preparing regulatory documents (e.g., briefing books, designation requests), and contributing to rapid response teams for clinical trial applications. Qualifications: 4-8 years in pharmaceutical regulatory affairs, with significant experience in US regulatory submissions, particularly INDs and NDAs, and a strong scientific background (PhD, MD, PharmD, BS/MS in regulatory science). Preferred skills include team leadership, influence, and project management, along with excellent communication and problem-solving capabilities. High-Value: Focus on hematology/oncology, biologics or cell therapy modalities, with involvement in clinical development phases; international regulatory coordination and FDA interactions; and a collaborative, cross-functional work environment. Work setup involves onsite or hybrid arrangements, with some travel expected.