Senior Manager, US Medical Ad/Promo Regulatory Review

Role: Senior Manager, US Medical Ad/Promo Regulatory Review, serving as an expert on FDA regulations impacting prescription drug and biologic product promotion. Responsibilities include interpreting complex regulatory requirements, mentoring staff, chairing promotional review meetings, and collaborating with cross-functional teams such as Regulatory Affairs, Medical, Legal, and Commercial. The role involves liaising with FDA review groups (OPDP, APLB), managing promotional review standards, supporting metrics and process improvements, and overseeing global promotional materials. Qualifications: Bachelor's degree in life sciences; 4+ years in Regulatory Affairs or related fields, with at least 2 years focused on Advertising and Promotion; knowledge of global and US promotional regulations; experience managing regulatory filings is preferred. Skills include strong regulatory judgment, communication, negotiation, and leadership capabilities, with some prior team management desirable. High-value specifics: US focus, remote work, up to 20% travel, and compensation range of $137,000–$215,270. The position emphasizes regulatory expertise in pharma promotion, with an understanding of FDA enforcement trends, global promotional standards, and cross-team collaboration.