VP, Regulatory Promotion and Advertising

Role: Vice President, Regulatory Affairs – U.S. Advertising & Promotion, leading Amylyx’s regulatory strategy for promotional communications supporting commercial and late-stage development products. Responsibilities: oversee advertising and promotion regulatory compliance, serve as FDA OPDP liaison, develop and implement governance and processes, guide cross-functional teams including Commercial, Medical Affairs, Legal, and Compliance, and support product launches like avexitide. Qualifications: bachelor’s degree with 12+ years, master’s with 10+ years, or PhD with 8+ years in US Ad/Promo regulation within pharma/biotech; deep FDA expertise, especially OPDP, and experience with FDA, ICH, EMA guidelines, and global submissions. Preferred: proven leadership in launch-stage product promotion, experience managing external vendors, and skills in digital/social media regulation. High-Value: focus on prescription drug advertising, digital initiatives, disease awareness campaigns, and scientific exchange in a growing biotech environment. Work setup: remote within the U.S., with travel to Cambridge, MA several times a year; salary range $314K–$353K.