Regulatory Affairs Director

Job Summary

Providing strategic regulatory leadership for promotional materials, the full-time remote Regulatory Affairs Director will ensure compliance with FDA regulations and industry standards while collaborating with cross-functional teams to shape messaging strategies and mitigate regulatory risks.

Key responsibilities

• Serve as the Ad Promo regulatory lead for assigned products, providing proactive guidance on promotional strategy and claims development
• Lead the review and approval of promotional materials, ensuring accuracy and compliance through the Medical, Legal, and Regulatory review committee
• Monitor FDA enforcement actions and support inspection readiness activities related to promotional review processes

Required qualifications

• Advanced scientific degree (PharmD, PhD, MD) or equivalent
• 8+ years of pharmaceutical experience with 5+ years of relevant advertising and promotion experience
• Deep understanding of FDA promotional regulations and OPDP expectations
• Experience supporting commercial launches and/or late-stage development programs
• Demonstrated ability to influence cross-functional stakeholders in a matrixed environment