Director, Regulatory Advertising and Promotion

About the role

The Director, Regulatory Advertising & Promotion leads the U.S. advertising and promotion regulatory function for Genetix Biotherapeutics’ cell and gene therapy portfolio. Reporting to senior leadership, the role ensures all promotional materials meet FDA requirements while supporting commercial objectives in a hybrid work environment.

Key responsibilities

• Oversee regulatory review of all U.S. promotional and selected non‑promotional content across multiple channels, ensuring compliance with current FDA regulations and enforcement trends.
• Act as the regulatory lead for Medical‑Legal‑Regulatory (MLR) reviews, coordinating with Commercial, Medical Affairs and Legal teams.
• Monitor FDA enforcement actions and policy updates, translating insights into internal guidance, SOPs and best‑practice tools.
• Develop and execute submission strategies for health‑authority review of promotional materials, managing electronic submission databases and collaborating with Regulatory Operations.
• Maintain and improve SOPs, workflows, training programs, and escalation processes to drive consistency and operational excellence.

Required profile

• Advanced degree (PharmD, PhD, MD, JD or equivalent) with a strong scientific background.
• Minimum 10 years of regulatory experience in biotech or pharmaceutical companies, including FDA interactions related to promotional compliance.
• Demonstrated experience with MLR review processes.
• Prior exposure to cell and gene therapy or rare‑disease products is strongly preferred.

Required skills