Senior Director, Regulatory Labeling & Advertising Promotion

About the role

The Senior Director, Regulatory Labeling & Advertising Promotion leads global product labeling and U.S. advertising and promotion regulatory activities for Genetix’s cell and gene therapy portfolio. This hybrid role (3 days onsite) provides strategic and operational leadership to ensure all labeling and promotional materials are scientifically accurate, compliant, and aligned with corporate objectives.

Key responsibilities

• Lead development, negotiation and lifecycle maintenance of global and U.S. product labeling, including pre‑ and post‑approval updates.
• Drive creation and upkeep of Company Core Data Sheets (CCDS) and Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Provide regulatory leadership for labeling interactions with health authorities, preparing briefing documents and responding to inquiries.
• Oversee regulatory review of U.S. promotional and selected non‑promotional materials across channels, ensuring compliance with FDA regulations and enforcement trends.
• Serve as regulatory lead for Medical‑Legal‑Regulatory (MLR) review and partner with Commercial, Medical Affairs and Legal to mitigate regulatory risk.
• Monitor FDA enforcement actions and policy developments, translating insights into internal guidance and best practices.

Required profile

• Extensive experience (typically 10+ years) in regulatory affairs for cell and gene therapy products.
• Proven track record leading labeling and advertising/promotional regulatory programs in a global, highly regulated environment.
• Strong understanding of FDA labeling, advertising and promotion regulations and enforcement trends.
• Excellent communication and partnership skills with Clinical Development, Medical Affairs, Commercial, Legal and Safety functions.

Required skills