Manager, US Medical Ad/Promo Regulatory Review

Role: Manager, US Medical Ad/Promo Regulatory Review, providing expert guidance on FDA regulations for prescription drug and biologic product promotion. Responsibilities: oversee regulatory compliance of promotional materials for assigned products or therapeutic areas; collaborate with Regulatory Affairs, Medical, Legal, and Compliance teams; evaluate advertising content against FDA guidance, corporate standards, and legal requirements; support development of marketing and labeling strategies; chair promotional review meetings; monitor regulatory trends and enforce standards within electronic approval systems; suggest process improvements. Qualifications: bachelor's in life sciences; 3+ years in regulatory affairs related to drugs or biologics, including 1+ years in advertising and promotion; strong knowledge of FDA regulations; excellent communication skills; ability to interpret scientific data and regulatory requirements; regulatory or clinical experience preferred; RAC certification desirable. HighValue: US-based, remote; travel up to 20%; focus on prescription drugs/biologics promotion, regulatory compliance, cross-functional collaboration, and FDA guidance interpretation.