Head of Regulatory Advertising & Promotion

Head of U.S. Regulatory Advertising & Promotion

The Head of U.S. Regulatory Advertising & Promotion is a senior leadership role responsible for providing strategic regulatory oversight for promotional and non-promotional communications across the U.S. business. This individual will serve as the A&P SME ensure that advertising, promotional, and educational materials comply with applicable regulatory requirements while supporting business objectives and enabling compliant growth.

Key Responsibilities

• Develop and execute regulatory advertising and promotion strategies that support commercial objectives while ensuring compliance with applicable regulations and industry standards.
• Establish and maintain policies, procedures, and governance frameworks that promote consistent, risk-based decision-making across promotional activities.
• Partner closely with cross-functional stakeholders, including Medical Affairs, Legal, Commercial, Marketing, and Compliance, to provide strategic regulatory guidance on promotional and educational materials.
• Lead regulatory review and approval of promotional content to ensure alignment with approved product labeling, scientific evidence, and applicable regulatory requirements.
• Serve as the primary regulatory advisor for interactions related to promotional compliance matters with U.S. health authorities, including submission strategies, risk assessments, and responses to regulatory inquiries.
• Build and maintain a high-performing advertising and promotion function, driving operational excellence, process improvements, and efficient review workflows.
• Provide leadership, coaching, and development for a team of regulatory professionals.
• Monitor evolving regulatory requirements, guidance, and enforcement trends, translating external developments into practical business recommendations and risk mitigation strategies.
• Collaborate with global and regional regulatory colleagues to promote consistency and alignment in advertising and promotion practices worldwide.
• Participate in governance committees and cross-functional forums to influence business strategy and support compliant product commercialization.

Qualifications

• Bachelor's degree in a scientific discipline or related field required; advanced degree (MS, PharmD, MD, or equivalent) preferred.
• Minimum of 10 years of Regulatory Advertising & Promotion experience within the pharmaceutical, biotechnology, or related life sciences industry.
• Extensive knowledge of U.S. regulatory requirements governing pharmaceutical advertising and promotion.
• Strong understanding of regulatory guidance, enforcement trends, and promotional compliance expectations.
• Prior people management experience is preferred
• Experience reviewing and advising on a broad range of promotional and medical communications.
• Demonstrated success collaborating with cross-functional stakeholders and influencing business decisions in a complex environment.
• Experience leading promotional review committees and regulatory decision-making processes.
• Excellent communication, presentation, analytical, and project management skills.
• Strong organizational skills with the ability to manage multiple priorities and deadlines..
• Ability to operate effectively within a hybrid work environment and travel periodically as needed.