Executive Director, Regulatory Strategy, Cell & Gene Therapy

Role: Executive Director of Regulatory Strategy specializing in Type 1 Diabetes (T1D), leading global regulatory development and implementation for portfolio products from FIH to post-marketing stages. Responsibilities: develop and oversee global regulatory strategies, ensure alignment with corporate goals, coordinate with regional teams, contribute to regulatory submissions and health authority communications, advise senior leadership, and lead a team of regulatory professionals. Also involved in industry representation and continuous process improvement. Requirements: Bachelor's in Biology, Chemistry, or related field; 15+ years in pharmaceutical/biotech regulatory affairs; 7+ years of supervisory experience; deep expertise in drug development, global regulatory frameworks, and strategic health authority interactions. HighValue: T1D therapeutic area, drug development from early to post-market phases, global regulatory leadership, experience with complex biologics or advanced modalities preferred. WorkSetup: Hybrid or on-site, flexible work arrangement.