Director/Sr. Director, US Regulatory Advertising and Promotion

Role: Lead regulatory advertising and promotion activities for cell and gene therapy products at Genetix Biotherapeutics, ensuring compliance with FDA regulations. Responsibilities: oversee review of promotional/non-promotional materials, serve as regulatory lead in Medical-Legal-Regulatory reviews, partner with Commercial, Medical Affairs, and Legal to mitigate regulatory risks, develop submission strategies, and monitor FDA enforcement trends. Also, establish and improve SOPs, workflows, and training related to promotional review. Qualifications: advanced degree (PharmD, PhD, MD, JD) preferred; 10+ years of regulatory experience in biotech or pharma, especially supporting FDA interactions and MLR review; experience in cell/gene therapy or rare diseases highly desirable. Skills: deep understanding of FDA promotional regulations, leadership in cross-functional teams, problem-solving ability, excellent communication, and risk-based judgment. Work setup: full-time hybrid role based in Somerville, MA, with onsite presence required three days/week.