Director, Regulatory Advertising & Promotion

📋 Description

• Serve as regulatory SME on U.S. FDA advertising and promotion for assigned products
• Review and approve promotional and medical materials for FDA compliance
• Lead interactions with FDA OPDP and review divisions as primary regulatory contact
• Oversee OPDP/FDA submissions and prepare high-quality materials for review
• Manage regulatory inquiries and discuss matters with FDA personnel
• Provide strategic regulatory input during commercial planning

🎯 Requirements

• Bachelor’s degree in a scientific field
• 8+ years pharma experience, 6+ in regulatory affairs
• Expert knowledge of U.S. FDA advertising and promotion regulations
• Strong experience in promotional/medical comms review and approval
• Direct experience with FDA OPDP and APLB on submissions and agency interactions
• Proven ability to oversee and author OPDP submissions

🎁 Benefits

• $177,000–$260,000 USD annual base salary
• Eligibility for short-term incentive program
• Eligibility for long-term incentive program
• Opportunity to contribute to transformative medicines and patient outcomes
• Collaborative environment with exposure to commercial, medical, legal, regulatory, and exec
• Emphasis on inclusion, growth, and development