Regulatory Affairs Director

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