Senior Manager, US Medical Ad/Promo Regulatory Review

Role: Senior Manager, US Medical Ad/Promo Regulatory Review, providing expertise on FDA regulations and guidance to ensure compliant promotional materials for prescription drugs and biologics. Responsibilities include interpreting complex regulatory issues, mentoring staff, chairing promotional review meetings, liaising with FDA reviewers, and collaborating with cross-functional teams (Medical, Legal, Commercial, Compliance). The role involves managing regulatory risks, providing strategic guidance, and supporting process metrics improvement. Qualifications: Bachelor's in life sciences; 4+ years in regulatory affairs, with at least 2 years focused on advertising and promotion within pharma/biotech. Preferred: advanced degrees (PharmD, PhD, MS, MBA, JD), regulatory filing experience, and RAC certification. Knowledge of global advertising regulations, enforcement trends, and clinical development processes is essential. The position requires up to 20% travel, primarily within the US, and offers remote work within Massachusetts. High-value specifics include expertise in pharma promotion regulation, global coordination, and senior stakeholder engagement.