Senior Manager, US Medical Ad/Promo Regulatory Review

Role: Senior Manager, US Ad/Promo Regulatory Review, focusing on ensuring regulatory compliance of promotional materials for prescription drugs and biologics in the US. Responsibilities include acting as primary regulatory reviewer, providing strategic guidance on FDA regulations, preparing advisory comments and FDA interactions, chairing review meetings, and collaborating cross-functionally with Regulatory Affairs, Medical, Legal, Compliance, and Commercial teams. The role involves monitoring FDA guidance and enforcement trends, assessing promotional content for accuracy and compliance, and advising on product labeling strategies. Requirements: Bachelor’s in life sciences or related field; 4+ years in Regulatory Affairs or related experience, including 2+ years in Ad/Promo review; strong knowledge of FDA regulations governing prescription drug and biologic promotion; proficiency in regulatory strategy and cross-team collaboration; leadership and mentoring skills. Preferred: Advanced degree (PharmD, MS, MBA, JD), RAC certification. HighValue: US prescription drug/biologic promotion, FDA regulatory environment, cross-functional stakeholder engagement, experience with medical communications, and regulatory interactions. Location: Remote Massachusetts; travel up to 25% including potential international trips.