Director, Regulatory Affairs Advertising & Promotion, US

About the role

The Director, Regulatory Affairs Advertising & Promotion, US leads the development and execution of regulatory strategies for all advertising and promotional activities across the United States. This senior position serves as the primary expert on FDA requirements, ensuring that all communications—including promotional, disease‑state, and scientific exchange materials—are fully compliant.

Key responsibilities

• Lead and manage the US Materials Review processes (LMR & PARC) for promotional, non‑promotional, scientific exchange and external communications.
• Ensure compliant review and approval of all professional and direct‑to‑consumer materials for approved US products managed by Averitas.
• Oversee review of investigational product materials to prevent pre‑approval promotion.
• Build strong partnerships with Medical, Legal and other cross‑functional teams to enable timely decision‑making.
• Act as Subject Matter Expert on FDA advertising and promotion regulations, guiding launch strategies, branding and campaign concepts.
• Collaborate with Global Regulatory Affairs to align US promotional and sales training materials with current prescribing information.
• Serve as primary liaison to FDA’s Office of Prescription Drug Promotion (OPDP) and manage FDA Form 2253 submissions.
• Advise US Commercial teams on regulatory requirements and risk‑based best practices.

Required profile

• Demonstrated expertise in FDA advertising and promotion regulations for pharmaceutical products.
• Experience overseeing review of promotional materials for both approved and investigational products.
• Proven ability to collaborate with cross‑functional teams including Medical, Legal and Regulatory Affairs.
• Strong knowledge of FDA Office of Prescription Drug Promotion (OPDP) processes and Form 2253 submissions.

Required skills

What we offer

• Salary range $205,000 – $240,000 per year.
• Long‑Term Incentive Plan equal to 25% of base salary.
• Annual performance bonus target of 25% of base salary.