Director Regulatory Advertising & Promotion

Director, Regulatory Affairs - Advertising & Promotion

Position Summary
Seeking an experienced regulatory leader to oversee U.S. and global advertising and promotional activities for advanced therapies, biologics, combination products, and medical devices. This role ensures all promotional and non-promotional materials are accurate, compliant with FDA and global standards, and aligned with business objectives. The ideal candidate brings deep regulatory expertise, proven leadership in promotional review, and strong cross-functional collaboration skills.

Key Responsibilities

• Provide strategic regulatory guidance for advertising and promotional activities across multiple product platforms.
• Review and approve promotional and scientific materials for compliance, accuracy, and fair balance.
• Chair Medical, Legal, Regulatory (MLR) review meetings and drive efficient, compliant processes.
• Serve as primary contact with FDA OPDP/APLB and other health authorities.
• Monitor regulatory trends and communicate implications to stakeholders.
• Develop and implement SOPs, best practices, and training for promotional compliance.
• Advise on promotional considerations during product development, launch, and lifecycle management.

Qualifications

• 10+ years of Regulatory Affairs experience, including 5+ years in advertising and promotion for prescription drugs or biologics.
• Expertise in FDA/OPDP/APLB regulations and global promotional standards.
• Proven success managing promotional review committees and regulatory authority interactions.
• Strong communication, leadership, and cross-functional collaboration skills.
• Bachelor's degree in a scientific discipline; advanced degree preferred.

Why Join?

• Work on cutting-edge regenerative medicine products transforming patient care.
• Be part of a growing organization with career advancement opportunities.
• Collaborate with passionate professionals in a dynamic, innovative environment.

Salary Range: $190,000 - $230,000 annually