We are seeking an experienced Senior Program Director – Commercial Regulatory Affairs (CORA) to lead regulatory review activities supporting commercial pharmaceutical products. This individual will serve as the regulatory lead for Promotional Review Committees (PRCs), partnering with cross-functional teams to ensure promotional materials and marketing strategies comply with FDA regulations and company policies.
The ideal candidate has extensive experience in Commercial Regulatory Affairs, FDA Advertising & Promotion (Ad/Promo), Medical Legal Regulatory (MLR) review, Form FDA 2253 submissions, and cross-functional leadership within the pharmaceutical or biotechnology industry.
Key Responsibilities
• Lead and chair Promotional Review Committees (PRCs) for assigned products and therapeutic areas.
• Provide strategic regulatory guidance on promotional and disease-state materials.
• Review advertising and promotional content for FDA compliance.
• Represent Regulatory Affairs in cross-functional meetings with Commercial, Medical, Legal, Compliance, and Marketing teams.
• Lead FDA communications, including Form FDA 2253 submissions.
• Support product launches and promotional strategy from a regulatory perspective.
• Interpret FDA regulations, guidance documents, and enforcement trends.
• Mentor junior regulatory professionals and contribute to process improvements.
Required Qualifications
• Bachelor's degree required; Advanced degree (JD, MBA, MS, PharmD, PhD) preferred.
• 7+ years of experience in Regulatory Affairs, Commercial Compliance, Legal, or related functions within the pharmaceutical or biotechnology industry.
• Strong experience in FDA Advertising & Promotion (Ad/Promo).
• Experience leading Promotional Review Committees (PRCs) or Medical Legal Regulatory (MLR) reviews.
• Deep knowledge of FDA regulations, healthcare compliance, promotional review, and Form FDA 2253.
• Excellent leadership, communication, stakeholder management, and project management skills.