Senior Director, Regulatory Affairs, Advertising, Promotion and Labeling

Responsibilities

• Serve as the Regulatory Lead and primary regulatory approver for the Promotional Material Review Committee (PRC) and Medical and Scientific Review Committee (MSRC) for assigned products.
• 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.
• Oversee the preparation and timely submission of all approved promotional materials to the FDA on Form FDA 2253 and other required regulatory submissions.
• 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.
• Lead the development, review, approval, and maintenance of the Company Core Data Sheet (CCDS), USPI and Patient Labeling.
• Chair or co-lead the labeling working group, driving cross-functional consensus on labeling content based on scientific data, clinical trial results, and regulatory requirements.
• Develop and execute strategic global labeling implementation plans to incorporate new safety and efficacy data, ensuring timely distribution and compliant use across all markets.
• Collaborate with Global Regulatory Leads on labeling negotiations with Health Authorities, ensuring that commercialization objectives are adequately supported by the final approved labeling.
• Lead, mentor, and develop a high-performing team of regulatory professionals focused on Ad/Promo and Labeling.
• Develop and maintain robust Standard Operating Procedures (SOPs) and work instructions for the Ad/Promo review and labeling maintenance processes.
• Ensure the effective and compliant use of electronic submission and review systems (e.g., Veeva PromoMats or similar).
• Conduct and oversee regulatory compliance training for Marketing, Sales, Medical Affairs, and Legal teams on promotional regulations (e.g., FD&C Act, PhRMA Code).
• Manage budget and resource allocation for the Ad/Promo and Labeling functions.

Qualifications

• BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred 10+ years required of regulatory pharmaceutical industry experience and extensive experience (at least 7 years) in advertising and promotion regulatory affairs including participation on PMRCs, or equivalent experience.
• Thorough understanding of regulatory requirements for compliant advertising and promotional materials.
• History of providing creative solutions to Commercial and Medical Affairs teams exhibiting superior judgment and a balanced, realistic understanding of issues.
• Outstanding interpersonal and communication (written and verbal) skills.
• Attention to detail and highly organized.
• Fluency in English as business language.
• Experience working with Veeva PromoMats.