Executive Director, Regulatory Strategy

Role: Executive Director of Regulatory Affairs responsible for overseeing global regulatory strategies for new development programs from pre-IND to post-approval stages. Primary objectives include ensuring timely and compliant submissions (INDs, NDAs, BLAs), managing interactions with regulatory agencies, and leading a regulatory team. Responsibilities involve developing registration strategies, maintaining FDA relationships, overseeing document quality, and guiding clinical and CMC regulatory activities. Qualifications: BS/BA with 18+ years, MS/MA with 16+ years, or PhD with 15+ years' experience in pharma/regulatory, with extensive oncology regulatory experience; prior FDA interaction experience preferred. Knowledge of US and international regulations, leadership in complex programs, and strategic planning skills are required. High-Value: Oncology drug development, regulatory submissions, clinical and CMC regulation, FDA engagement, and team leadership. Work setup: primarily indoor office environment.