The Opportunity

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.

Responsibilities

• 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 perspective.
• Foster a culture of collaboration, accountability, continuous improvement, and regulatory excellence.

Required Qualifications

• Bachelor’s degree with 12+ years, Master’s degree with 10+ years, or PhD with 8+ years of relevant experience in US Advertising and Promotion within the biotechnology or pharmaceutical industry.
• Deep expertise in FDA regulations, guidance, enforcement trends, and industry practices governing prescription drug advertising and promotion, including extensive experience wirth FDA’s Office of Prescription Drug Promotion.
• Demonstrated experience providing strategic regulatory leadership for commercial and launch-stage products, including promotional review, labeling implications, disease awareness, scientific exchange, digital/social media, payer communications, and other external communications.
• Expert knowledge of FDA, ICH, EMA, GCP, eCTD, and global regulatory submission requirements.
• Experience establishing or evolving Ad/Promo governance, processes, standards, and operation models within a growing organization.
• Demonstrated experience leading cross-functional teams and influencing senior stakeholders without direct authority.
• Proven ability to manage multiple high-priority programs simultaneously in a fast-paced development environment.
• Strong project leadership, organizational, and communication skills.
• Experience managing external medical writing vendors and outsourced writing activities.
• Advanced proficiency with Microsoft Office, Adobe Acrobat, document management systems, SharePoint, and structured content management platforms.
• Ability to interpret complex clinical data and translate scientific findings into clear, concise, and scientifically rigorous regulatory documents.
• Experience supporting multiple regulatory submissions, including INDs, NDAs, BLAs, or equivalent global filings.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.