Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

Role: Senior Director, Regulatory Affairs - Oncology, leading global regulatory strategies for high-complexity oncology products in late-stage development. Responsibilities: develop and execute global regulatory plans to support product approval, lead Regulatory Teams (GRTs), guide cross-functional teams in regulatory submissions (clinical trials, marketing applications), and manage interactions with regulatory agencies. Ensure compliance with evolving global regulations, optimize regulatory pathways (e.g., orphan, accelerated approval), and drive process improvements. Qualifications: Doctorate (PhD, MD, or equivalent) with 5+ years of biotech/science regulatory experience, including 5 years of management leadership; or Master’s with 9+ years, or Bachelor’s with 11+ years. Preferred: oncology experience, leadership in complex programs, successful submissions for major marketing applications, strong communication, strategic thinking, and global collaboration skills. High-Value: oncology therapeutic area, late-stage development, global regulatory strategy, complex programs, cross-functional leadership, and agency negotiations. Work setup: Not specified; sponsorship not guaranteed.