Senior Director, Regulatory Strategy

Role: Senior Director of Regulatory Strategy responsible for developing and executing global regulatory approaches for complex development programs, including emerging diseases, existing Vertex medicines, or marketed products. Objectives: shape cohesive regulatory strategies across development and commercial phases, ensure integration with franchise goals, and influence regulatory environments through industry engagement. Responsibilities: lead regulatory strategy for projects from FIH to post-marketing, represent GRA on core teams, provide advanced guidance on regulatory issues, manage project plans, and lead continuous process improvements. Also, oversee GRA functional teams, mentoring, and resource allocation. Requirements: Bachelor's in Biology, Chemistry, or related field; 12+ years in pharma/biotech regulatory affairs; 5+ years in leadership roles; deep knowledge of global/regional/local regulatory frameworks, clinical development, and submission processes; strong leadership, communication, and strategic thinking skills. Preferred: experience in biologics or small molecules, early to late-stage development, and cross-functional collaboration. High-value: global/regional scope, complex project oversight, regulatory interactions, and industry participation, hybrid work model (3 days onsite in Boston or Washington, D.C.), with some travel. This senior leadership role emphasizes strategic planning, cross-functional influence, and regulatory expertise in biopharma development and commercialization.