Regulatory Affairs Program Manager

Role: Regulatory Affairs Program Manager overseeing cross-functional regulatory projects from strategy through execution, ensuring global compliance and timely product launches. Responsibilities: lead regulatory planning, act as internal point of contact, coordinate teams, track program progress, conduct regulatory intelligence, and develop risk mitigation strategies. Requirements: Bachelor's in sciences, business, or related field; 5+ years' experience, including 4+ years in pharmaceutical, biologics, or med device industries; 3+ years managing multi-regional programs. High-Value: experience with FDA and major health authorities, biologics or cell/gene therapy modalities, and global regulatory strategy. Work Setup: on-site position with standard Monday–Friday hours; no travel specified.