Associate Director Global Regulatory Sciences - Oncology

Role: Associate Director, Global Regulatory Strategy in Hematology/Oncology, leading regulatory development and lifecycle management for oncology therapeutics. Responsibilities: develop global and US regulatory strategies, oversee submission of INDs, BLAs, NDAs, and supplements, ensure quality and compliance in dossiers, manage cross-functional contributions, write and review regulatory documents, and lead interactions with FDA and other health authorities. Qualifications: PhD, MD, PharmD, or equivalent; 4-8 years in pharma, with significant regulatory affairs experience and strong knowledge of IND/NDA processes. Preferred: extensive US regulatory submission experience, team leadership skills, project management expertise, and ability to influence cross-functional teams. High-Value: focus on oncology (hemato-oncology), lifecycle management, FDA interactions, global submission planning, and cross-functional collaboration. Work Setup: likely hybrid or onsite, with some travel required.