Specialist, Regulatory Affairs Advertising & Promotion Review

Leads regulatory reviews of external communications intended for healthcare professionals (HCPs), patients and caregivers, ensuring high-quality, accurate and compliant content aligned with US laws, Food and Drug Administration (FDA) regulations and guidance, Pharmaceutical Research and Manufacturers of America (Ph. RMA) principles and company policies. Provides authoritative regulatory advice on promotional content, evaluate promotional claims, and develops compliant strategies in collaboration with Commercial, Medical and other relevant teams. Ensures product promotion materials are consistent with FDA-approved labeling and effectively manage related submission processes. Oversees timely and accurate submissions of promotional materials using FDA Form 2253 Establishes, enhances and streamlines regulatory review processes, promoting best practices and operational excellence. Acts as a regulatory subject-matter expert in cross-functional meetings, ensuring alignment on regulatory requi...Regulatory Affairs, Regulatory, Specialist, Advertising, Business Services