Associate Director, Promotional Regulatory Affairs

Role: Associate Director of Promotional Regulatory Affairs overseeing FDA promotional compliance for AstraZeneca's pharmaceutical products. Primary objectives include ensuring regulatory review and risk assessment of promotional materials across all segments and media, providing strategic guidance, and representing AZ to regulatory authorities. Responsibilities encompass managing review processes through AZAP, advising cross-functional teams on FDA regulations, developing PRA guidance, and monitoring regulatory trends. Requirements: Bachelor's in pharmacy, pharmacology, or related field; 5+ years in drug/biologic regulatory affairs; working knowledge of FDA promotional regulations and drug development; experience with electronic review tools preferred. Desirable: therapeutic area experience, influencing skills, team collaboration, strategic thinking, and adaptability. High-value: focus on promotional compliance within the US, in a fast-paced, collaborative environment; in-person work with a hybrid model; experience with VEEVA PromoMats advantageous.