VP, Regulatory Promotion and Advertising
Amylyx Pharmaceuticals
August 14, 2026
Remote friendly (Cambridge, MA)
United States
Marketing
Responsibilities:
- Provide executive leadership for U.S. Advertising & Promotion Regulatory Affairs across all commercial and late-stage development programs.
- Be the primary regulatory expert on FDA advertising/promotion requirements, OPDP guidance, enforcement trends, and evolving regulatory policy.
- Partner with Commercial to develop compliant promotional strategies for product launches and lifecycle management.
- Lead regulatory representation on Promotional Review Committees (PRC/MLR).
- Provide strategic regulatory guidance for: consumer/HCP promotional materials, disease awareness, scientific exchange, digital/social initiatives, corporate and investor communications (product information), patient education/advocacy, and payer communications.
- Serve as primary liaison with FDA OPDP (advisory/voluntary submissions, enforcement responses, and interactions).
- Collaborate cross-functionally (Regulatory Strategy, Medical Affairs, Clinical Development, Legal, Compliance, Commercial Operations, Market Access, Corporate Communications, Patient Advocacy).
- Develop Ad/Promo regulatory strategies, build scalable governance/processes/operating procedures, assess promotional regulatory risk, and monitor FDA guidance/enforcement trends.
- Develop/mentor the Ad/Promo regulatory organization; support due diligence, business development, and pipeline planning from an Ad/Promo regulatory perspective.
Required Qualifications:
- BS (12+ years) / MS (10+ years) / PhD (8+ years) in U.S. Advertising & Promotion in biopharma.
- Deep expertise in FDA advertising/promotion regulations, guidance, enforcement trends; extensive experience with FDA OPDP.
- Strategic regulatory leadership for launch-stage/commercial products (promotion review, labeling implications, disease awareness, scientific exchange, digital/social, payer communications).
- Expert knowledge of FDA, ICH, EMA, GCP, eCTD, and global submission requirements.
- Experience establishing/evolving Ad/Promo governance/processes; leading cross-functional teams without direct authority.
- Proven ability to manage multiple high-priority programs; strong project leadership/communication.
- Experience managing medical writing vendors; advanced MS Office/Adobe Acrobat, document management systems/SharePoint/content platforms.
- Ability to interpret clinical data and draft rigorous regulatory documents; experience supporting IND/NDA/BLA (or equivalent) submissions.
- Provide executive leadership for U.S. Advertising & Promotion Regulatory Affairs across all commercial and late-stage development programs.
- Be the primary regulatory expert on FDA advertising/promotion requirements, OPDP guidance, enforcement trends, and evolving regulatory policy.
- Partner with Commercial to develop compliant promotional strategies for product launches and lifecycle management.
- Lead regulatory representation on Promotional Review Committees (PRC/MLR).
- Provide strategic regulatory guidance for: consumer/HCP promotional materials, disease awareness, scientific exchange, digital/social initiatives, corporate and investor communications (product information), patient education/advocacy, and payer communications.
- Serve as primary liaison with FDA OPDP (advisory/voluntary submissions, enforcement responses, and interactions).
- Collaborate cross-functionally (Regulatory Strategy, Medical Affairs, Clinical Development, Legal, Compliance, Commercial Operations, Market Access, Corporate Communications, Patient Advocacy).
- Develop Ad/Promo regulatory strategies, build scalable governance/processes/operating procedures, assess promotional regulatory risk, and monitor FDA guidance/enforcement trends.
- Develop/mentor the Ad/Promo regulatory organization; support due diligence, business development, and pipeline planning from an Ad/Promo regulatory perspective.
Required Qualifications:
- BS (12+ years) / MS (10+ years) / PhD (8+ years) in U.S. Advertising & Promotion in biopharma.
- Deep expertise in FDA advertising/promotion regulations, guidance, enforcement trends; extensive experience with FDA OPDP.
- Strategic regulatory leadership for launch-stage/commercial products (promotion review, labeling implications, disease awareness, scientific exchange, digital/social, payer communications).
- Expert knowledge of FDA, ICH, EMA, GCP, eCTD, and global submission requirements.
- Experience establishing/evolving Ad/Promo governance/processes; leading cross-functional teams without direct authority.
- Proven ability to manage multiple high-priority programs; strong project leadership/communication.
- Experience managing medical writing vendors; advanced MS Office/Adobe Acrobat, document management systems/SharePoint/content platforms.
- Ability to interpret clinical data and draft rigorous regulatory documents; experience supporting IND/NDA/BLA (or equivalent) submissions.