Associate Director/ Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)

Role: Associate Director of Regulatory Affairs for Advertising and Promotion, focusing on US prescription drug promotional materials. Responsibilities: provide strategic regulatory review and guidance across multiple channels (digital, print, speaker programs, congresses); lead or support US promotional review committees (MLR); manage FDA submissions (FDA 2253); monitor industry enforcement trends; support product launch activities; develop internal policies and SOPs; mentor junior staff; collaborate cross-functionally to ensure compliant, effective promotional strategies. Requirements: Bachelor's in life sciences or related field; 7+ years in Regulatory Affairs Advertising & Promotion within pharma/biotech; strong knowledge of FDA-OPDP regulations, MLR processes; experience with US promotional material review and FDA submissions; familiarity with review systems like Veeva PromoMats. Preferred: product launch experience; background in specialty, rare disease, oncology; global promotional regulatory experience; fast-paced biotech environment. High-Value: US prescription drug promotion, FDA regulatory oversight, cross-functional coordination, digital and multi-channel marketing, product launch support. WorkSetup: not specified.