Regulatory Strategy Associate Director

Role: Lead the development of global regulatory strategies for development programs and marketed products within Vertex's portfolio, serving as a regulatory lead for both development and commercial stages. Responsibilities: oversee regulatory planning, facilitate health authority interactions, advise on development and approval pathways including expedited options, and ensure regulatory compliance across submissions. Provides strategic input for registration documents and monitors evolving regulations and guidance. Mentors team members and influences cross-functional teams on regulatory risks and strategies. Requirements: bachelor's in biology, chemistry, or related field; 8+ years in pharmaceutical or biotech regulatory affairs; deep knowledge of global/regional regulatory frameworks, drug development processes, and health authority submission procedures. Skills: strong scientific assessment, problem-solving, communication, leadership, and proficiency with emerging technologies including AI-driven tools. Experience with major health authority submissions and interactions is essential. High-Value: global/regional regulatory strategy, biotech/pharma, drug development, clinical trial design, regulatory intelligence, and compliance for products in development or marketed. Work setup: hybrid or on-site; flexible work arrangement.