OverviewThe Senior Director, Regulatory Affairs Advertising, Promotion (Ad/Promo), and Labeling is a critical leadership role responsible for developing and executing regulatory strategy for all product communications and core labeling. This leader will ensure that all commercial and non-promotional materials, as well as core and local product labeling, are compliant with US FDA, EMA, and other relevant global regulations. The role requires expert-level interpretation of complex regulatory requirements and a proven ability to lead and influence cross-functional teams to achieve both compliance and business goals.
Responsibilities
Advertising & Promotion Strategy and Oversight
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.
Labeling Strategy and Management
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.
Leadership and Compliance Management
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.
Supervision Exercised:
Team of 1-4
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
Ability to travel up to 20% of the time domestically and internationally
Experience working with Veeva PromoMats
