Senior Manager or Associate Director, Regulatory Affairs (Advertising & Promotion)

This role will focus on the regulatory review of advertising and promotional materials, with a particular emphasis on products related to transplant care. You will report to a Director within the Regulatory Affairs team and serve as the primary point of contact for promotional review activities. • Review 150–300 promotional pieces per year, ranging from 2–250 pages each, ensuring timely turnaround and compliance with FDA regulations (21 CFR Part 202.1) and OPDP guidance. • Minimum 7 years of regulatory experience focused on advertising and promotional review in the biopharmaceutical industry. • Proven ability to provide clear, actionable regulatory guidance in a fast-paced environment.