VP, Regulatory Promotion and Advertising

VP, Regulatory Promotion and Advertising

Cambridge, MA

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below.

Amylyx Pharmaceuticals is seeking a Vice President, Regulatory Affairs – U.S. Advertising & Promotion (Ad/Promo) which serves as the strategic regulatory leader responsible for providing expert guidance on U.S. advertising, promotion, scientific exchange, and external communications supporting Amylyx's commercial and development-stage products. This individual partners closely with Commercial, Medical Affairs, Clinical Development, Legal, Compliance, Corporate Communications, and Executive Leadership to enable compliant commercialization strategies while effectively managing regulatory risk.

The Vice President will establish and lead the Company's U.S. Advertising & Promotion regulatory function, providing strategic oversight across launch planning, promotional review, disease awareness communications, digital initiatives, scientific exchange, patient engagement, payer communications, and future pipeline assets. This individual will represent Amylyx with FDA's Office of Prescription Drug Promotion (OPDP) and play a critical leadership role supporting the successful launch of avexitide and future commercial products.

We anticipate hiring the VP, Regulatory Promotion and Advertising in September 2026.

• Provide executive leadership for the U.S. Advertising & Promotion Regulatory Affairs function across all commercial and late-stage development programs.
• Serve as the Company's primary regulatory expert on FDA advertising and promotion requirements, OPDP guidance, enforcement trends, and evolving regulatory policy.
• Partner with Commercial leadership to develop compliant promotional strategies supporting successful product launches and lifecycle management.
• Lead Regulatory representation on Promotional Review Committees (PRC/MLR), ensuring promotional materials appropriately balance business objectives with regulatory compliance.
• Provide strategic regulatory guidance for:
• Consumer and healthcare professional promotional materials
• Disease awareness campaigns
• Scientific exchange
• Digital and social media initiatives
• Corporate communications
• Investor communications involving product information
• Patient education and advocacy materials
• Payer communications
• Serve as the primary liaison with FDA OPDP, including advisory comment submissions, voluntary submissions, enforcement responses, and other regulatory interactions.
• Collaborate cross-functionally with Regulatory Strategy, Medical Affairs, Clinical Development, Legal, Compliance, Commercial Operations, Market Access, Corporate Communications, and Patient Advocacy.
• Develop regulatory strategies that enable innovative communication approaches while maintaining compliance with FDA regulations and company policies.
• Build scalable Ad/Promo processes, governance models, and operating procedures to support organizational growth.
• Provide strategic risk assessments and recommendations to senior leadership regarding promotional initiatives.
• Monitor evolving FDA guidance, enforcement actions, and industry trends and proactively educate internal stakeholders.
• Develop and mentor a high-performing Advertising & Promotion regulatory organization as the commercial organization expands.
• Support due diligence, business development activities, and pipeline planning from an Advertising & Promotion regulatory…