Vice President, Global Promotional Advertising and Regulatory Affairs

Role Summary

Vice President, Global Promotional Advertising and Regulatory Affairs leads and oversees regulatory strategy, review and governance of all advertising, promotional, and scientific-exchange 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.

• Develop and lead the global regulatory advertising & promotion (Ad & Promo) strategy for the company’s 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 (e.g., FDA OPDP, state laws, industry codes, international laws and regulations).
• Manage and mentor staff supporting the promotional review process including review of concepts, claims, safety/risk language (e.g., ISI/brief summary), 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 (e.g., FDA OPDP), including submissions (e.g., Form 2253), advisory requests, and responses to enforcement letters or competitor complaints.
• Provide strategic regulatory advice and risk-based assessments to cross-functional stakeholders (Commercial/Marketing, Medical Affairs, Legal/Compliance, Regulatory Affairs operations), facilitating timely and compliant promotional launch campaigns and ongoing support for marketed products.
• Develop, implement and maintain standard operating procedures (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 (e.g., FDA guidance updates, industry enforcement actions, global codes of practice) 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, to ensure consistency where cross-border materials or campaigns are used.
• Ensure appropriate database/record-keeping for promotional materials, including submissions, approvals, regulatory correspondence, internal review archives, and audit readiness
• Other duties as assigned

• Required:
  
  Bachelor’s degree in Life Sciences (e.g., Biology, Chemistry, Pharmacy); advanced degree (Pharm
  
  D, PhD, MS) strongly preferred.
• Required:
  
  20+ years of relevant experience in regulatory affairs advertising & promotion (Ad/Promo) review, general regulatory strategy and labeling knowledge, and commercial compliance. Minimum of 10–15 years of experience in the pharmaceutical/biologics industry.
• Required:
  
  Deep knowledge of U.S. FDA advertising & promotion and labeling regulations (including OPDP, Form 2253 submissions, enforcement letters); familiarity with global regulatory codes of practice and international Ad/Promo requirements is ideal.
• Required:
  
  Demonstrated ability to operate cross-functionally in a matrixed environment, collaborate with Commercial, Medical Affairs, Legal/Compliance, Regulatory, and other stakeholders, influencing without direct authority.
• Required:
  
  Strong strategic, analytical, and risk-management mindset; ability to interpret complex regulatory standards, provide clear regulatory positions and business-oriented advice, and support launch assets and marketed brands.
• Required:
  
  Excellent verbal and written…