Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)

Role: Director/Sr. Director of Regulatory Affairs focusing on Oncology (Solid Tumors), responsible for developing and executing global regulatory strategies to support drug development, registration, and lifecycle management. Responsibilities: lead global submission planning (INDs, CTAs, NDAs, MAAs), ensure compliance with FDA, EMA, ICH guidelines, and facilitate agency interactions; manage cross-functional teams; develop risk mitigation strategies; support regulatory filings and agency meetings; oversee systems for document and information management; track submission milestones and participate in process improvements. Requirements: Bachelor's in life sciences with 12+ years in regulatory strategy, specifically within oncology; deep knowledge of regulatory frameworks and experience with clinical trial planning and submissions; strong project management skills with familiarity in tools like Veeva RIM and Smartsheet; excellent communication and organizational abilities. Preferred: advanced degree, proven success in global oncology filings, experience with regulatory systems. High-Value: oncology (solid tumor), global regulatory strategy, IND/CTA/NDA/MAA submissions, agency interactions, regulatory risk management, regulatory systems development. Work Setup: onsite in Brisbane, CA.