VP, Regulatory Promotion and Advertising

📋 Description

• Lead U.S. Advertising & Promotion regulatory affairs across commercial and late-stage
• Serve as regulatory expert on FDA advertising, OPDP guidance, and enforcement trends.
• Partner with Commercial to develop compliant promotional strategies for launches and lifecycle
• Lead PRC/MLR representation, balancing business objectives with regulatory compliance.
• Provide regulatory guidance for consumer materials, disease campaigns, scientific exchange, digital
• Act as primary liaison with FDA OPDP and manage regulatory interactions.

🎯 Requirements

• Bachelor’s degree with 12+ years, Master’s with 10+ years, or PhD with 8+ years in US
• Deep FDA regulatory expertise in prescription drug advertising and OPDP guidance.
• Strategic leadership for commercial/launch-stage products including digital/social media and
• Experience with FDA, ICH, EMA, GCP, eCTD, and global regulatory submissions.
• Proven governance, processes, and operating model development for Ad/Promo.
• -track record of cross-functional leadership and managing multiple high-priority programs.

🎁 Benefits

• Compensation range: $314,000 – $353,000 USD (estimate; final offer may vary).
• Remote work opportunities within the United States with travel to Cambridge, MA; some state hiring
• Equal Opportunity Employer with accommodations available in selection process.