Vice President, Global Promotional Advertising and Regulatory Affairs

Role Summary

The Head of Global Promotional Advertising & Regulatory Affairs leads and oversees the regulatory strategy, review and governance of all advertising, promotional, and scientific‚Äêexchange communications for prescription pharmaceutical/biologic products in the U.S. and internationally. This role ensures that promotional materials, campaigns, labeling, and other communications comply with applicable regulatory requirements while enabling the commercial objectives of the organization.

Responsibilities

• Develop and lead the global regulatory advertising & promotion strategy for the company‚Äôs marketed products and pipeline assets, in alignment with brand/commercial plans and overall regulatory strategy.
• Serve as the regulatory subject matter expert for promotional communications: advertising, sales aids, digital channels, medical education, disease awareness, conference exhibits, and scientific exchange materials. Ensure all materials comply with applicable laws, regulations, guidance documents, and internal policies.
• Manage and mentor staff supporting the promotional review process including review of concepts, claims, safety/risk language, and ensure labeling consistency. Monitor and respond to enforcement trends, advisory comments, and regulatory inquiries.
• Manage and mentor staff and/or act directly as a primary liaison with regulatory agencies, including submissions, advisory requests, and responses to enforcement letters or competitor complaints.
• Provide strategic regulatory advice and risk-based assessments to cross-functional stakeholders, facilitating timely and compliant promotional launch campaigns and ongoing support for marketed products.
• Develop, implement and maintain SOPs, guidelines, training programs, quality metrics and dashboards for the Ad & Promo review process, ensuring operational excellence and continuous improvement.
• Monitor and interpret regulatory developments and proactively update the business on implications for promotional communications and risk mitigation.
• Mentor, build, and lead the regulatory advertising & promotion team, fostering subject matter expertise, leadership, collaboration, and stakeholder engagement across the organization.
• Support global/regional harmonization of advertising & promotion regulatory framework, including collaboration with international/regional regulatory Ad & Promo leads.
• Ensure appropriate database/record-keeping for promotional materials, including submissions, approvals, regulatory correspondence, internal review archives, and audit readiness.
• Other duties as assigned

Qualifications

• Bachelor‚Äôs degree in Life Sciences required; advanced degree strongly preferred.
• 20+ years of relevant experience in regulatory affairs advertising & promotion, with 10‚Äì15 years in the pharmaceutical/biologics industry.
• Deep knowledge of U.S. FDA advertising & promotion and labeling regulations (OPDP, Form 2253, enforcement letters) and familiarity with global Ad/Promo requirements.
• Ability to operate cross-functionally in a matrixed environment, collaborating with Commercial, Medical Affairs, Legal/Compliance, Regulatory, and other stakeholders.
• Strong strategic, analytical, and risk-management mindset; ability to interpret complex regulatory standards and provide business-oriented advice.
• Excellent verbal and written communication skills; ability to articulate regulatory rationale and deliver training.
• Experience with promotional review systems (e.g., Veeva PromoMats) and metrics tracking is preferred.
• Leadership and team-building experience with ability to mentor regulatory professionals.

Skills

• Strategic thinking and regulatory-commercial alignment
• Cross-functional collaboration and influence
• Regulatory risk assessment and decision-making
• Regulatory communications and briefing for senior management
• Project and process management for Ad & Promo review
• Digital/promotional communications within regulatory context