VP, Regulatory Advertising & Promotion (PMRC)

This executive role provides strategic leadership and regulatory counsel in navigating the complex landscape of prescription drug advertising and promotion. The role holder will be responsible for developing and executing strategies that not only ensure stringent compliance with global health authority regulations (e.g., FDA, MHRA, OPDP) but also maximize the commercial potential and competitive positioning of Azurity’ s product portfolio.

 Key Strategic Accountabilities:

• Executive Regulatory Counsel & Risk Architecture: Influence and drive interpretation and application of advertising and promotion regulations. This involves proactively designing risk mitigation architectures that anticipate evolving regulatory landscapes, allowing for aggressive yet compliant promotional campaigns.
• Agency Negotiation & Influence (FDA/Global HAs): Act as the primary, influential, and respected liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) and other global regulatory bodies. This encompasses leading high-stakes negotiations, driving favorable interpretations of complex regulations, and shaping the dialogue surrounding novel promotional strategies.
• Integrated Commercial Strategy Leadership: Function as a key commercial thought partner, providing consultative leadership to cross-functional executive teams (Medical, Legal, Marketing,
• Commercial). The VP ensures seamless integration between regulatory strategy, long-term development plans, and enterprise-level commercial objectives, ensuring launch materials are strategically optimized for market impact from day one.
• Competitive Advantage through Compliance: Translate deep regulatory expertise into a tangible competitive advantage. This involves developing innovative promotional approaches while maintaining ironclad compliance, strategically positioning drug products to capture market share effectively and ethically.

Principle Responsibilities: 

• Spearheaded the design and implementation of a harmonized, enterprise-wide Global PMRC framework, standardizing risk assessment and benefit-risk evaluation processes across all product portfolios and international jurisdictions.
• Chair the Global Pharmacovigilance Risk Management Council (PMRC), leading strategic initiatives to identify, assess, and mitigate emerging safety signals, resulting in enhanced patient safety and regulatory compliance worldwide.
• Managed regulatory engagement and submissions for complex drug safety issues with a wide array of international health authorities, including the EMA, MHRA, Health Canada, and the China National Medical Products Administration (NMPA), ensuring alignment with diverse regional requirements.
• Develop and execute global compliance strategies for post-market surveillance and aggregate reporting (e.g., PBRERs), consistently achieving a 98% timely submission rate across FDA, EU, and other global markets.
• Serve as the primary liaison during major regulatory inspections and audits (e.g., EMA, MHRA), successfully demonstrating the robustness and effectiveness of the global PV system and ensuring positive inspection outcomes.
• Influence global regulatory convergence by participating in initiatives aligned with ICH guidelines and the International Coalition of Medicines Regulatory Authorities (ICMRA) objectives, helping to shape future regulatory standards.

Qualifications and Education Requirements

• Bachelor of Science in a scientific discipline; master’s or advanced degree preferred.
• 20+ years of regulated industry experience including regulatory review of promotional materials for prescription drug products.
• Proven track record in management of promotion review committees (e.g. PMRC).
• Deep knowledge and expertise in global regulatory environment, and global promotional guidance.
• Ability to collaborate and influence cross-functionally (Medical, Legal, Commercial, Marketing) and drive alignment while following regulatory regulations and requirements.
• Attention to detail, strong written and verbal communication skills.

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