Director – Regulatory Affairs

Job Description: • Lead hands-on regulatory submission activities with minimal oversight (Director). • Manage close communication with CROs to ensure on-time submissions and submission tracking. • Partner with Regulatory Operations and Medical Writing to ensure submissions meet global regulatory requirements and are delivered with high quality and on schedule. • Provide strategic regulatory recommendations across nonclinical, CMC, clinical development, companion diagnostics, and lifecycle management activities. • Monitor evolving global regulatory requirements and communicate potential impact on company programs. • Serve as the primary regulatory lead for the assigned program(s). • Lead regulatory planning for major development milestones. • Prepare for regulatory agency meetings, including Type B/C meetings characteristic of early-phase oncology programs. Requirements: • Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline. • Advanced degree (PharmD, PhD, MS, or equivalent) preferred. • Approximately 10–12 years of regulatory affairs experience within biotechnology or pharmaceutical drug development, including direct experience in oncology drug development. • Demonstrated experience leading regulatory submissions and strategy for oncology development programs, ideally spanning first-in-human through early efficacy stages. • Experience serving as regulatory lead for FDA interactions and major regulatory submissions. • Approximately 14+ years of progressive regulatory affairs experience, including oncology drug development (Senior Director). • Approximately 18+ years of progressive regulatory affairs experience (Executive Director). • Extensive knowledge of FDA, EMA, ICH, and other major global regulatory requirements. • Strong understanding of oncology drug development from First-in-Human through commercialization. • Experience with expedited regulatory pathways (Breakthrough Therapy, Fast Track, Accelerated Approval). Benefits: • base pay • annual performance bonus • company equity • comprehensive health benefits