Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling

Responsibilities

• Serve as regulatory lead and approver for promotional and medical review committees, providing practical, risk-based guidance on claims, supporting evidence, fair balance, and multichannel communications.
• Provide strategic, proactive regulatory guidance on the development of all promotional, advertising, and educational materials across all channels (print, digital, social media, speaker programs, formulary communications) to ensure fair balance and consistency with the US Prescribing Information (USPI).
• Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for advisory comments and managing responses to enforcement letters.
• Collaborate with Global Regulatory Leads on labeling negotiations with Health Authorities, ensuring that commercialization objectives are adequately supported by the final approved labeling.
• Direct development and maintenance of core, U.S., and patient labeling; lead cross-functional labeling alignment, global implementation, and support health authority negotiations.
• Establish and improve review processes, SOPs, systems, and training; monitor regulatory guidance and enforcement trends to mitigate risk.
• Develop and execute strategic global labeling implementation plans to incorporate new safety and efficacy data, ensuring timely distribution and compliant use across all markets.
• Monitor the competitive and regulatory landscape, including new guidance documents and enforcement actions, to proactively update internal policies and advise senior leadership on risk mitigation.
• Build and mentor the Ad/Promo and Labeling team, oversee vendors, and manage budgets and resources.
• Partner with Commercial, Medical Affairs, Legal, and Compliance to enable effective communications consistent with approved labeling and applicable U.S. and global requirements.
• Travel approximately 20%

Requirements

• BS or MS with requisite experience; advanced life sciences or medical degree (MD, Ph D, PharmD) preferred.
• 10+ years of biopharmaceutical regulatory experience, including at least 7 years of advertising and promotion or equivalent experience.
• Expertise in FDA promotional regulations, labeling, MLR review, promotional submissions, and OPDP interactions.
• Demonstrated product launch and lifecycle management experience; growth-stage biotech experience preferred.
• Strong leadership, scientific judgment, communication, and project management skills, with a collaborative, solutions-oriented approach.
• Experience with Veeva PromoMats or similar systems.
• Outstanding interpersonal and communication (written and verbal) skills.
• History of providing creative solutions to Commercial and Medical Affairs teams exhibiting superior judgment and a balanced, realistic understanding of issues.