Director Promotional Regulatory Affairs

Role: Director of Promotional Regulatory Affairs responsible for shaping US promotional strategies, ensuring regulatory compliance, and enabling effective brand communication across all media channels. Responsibilities include leading review and risk assessment of promotional materials, developing regulatory strategies, advising cross-functional teams on claims and labeling, and managing external FDA interactions. The role involves training development, process enhancement, monitoring regulatory trends, and representing the company as a subject matter expert. Collaboration spans Medical, Legal, Commercial, and Global teams, with external engagement with FDA agencies. The position also entails mentorship and leadership within the regulatory affairs team. Requirements: Bachelor's in science, 3+ years in promotional regulatory affairs, FDA (OPDP/APLB) experience, and 5+ years in pharma/biotech industry. Preferred qualifications include advanced degrees, 10+ years of US promotional regulatory experience, and digital review system familiarity. High-value details: Focus on pharmaceutical/biotech products in regulated promotional contexts, with a need for strategic risk management, compliance expertise, and cross-functional leadership to support product launches and lifecycle management in a fast-paced, innovative environment.