Maryland Licensed Regulatory Safety Lead

A company is looking for a Regulatory Safety Lead (MD). Key Responsibilities Oversee global pharmacovigilance operations, including case management and safety surveillance Represent the organization to regulatory authorities and manage safety interactions and inspections Support late-stage development and NDA/BLA submissions, specifically for the 2026 NDA submission Required Qualifications and Education MD required; prior experience as Head of Pharmacovigilance or Global Drug Safety preferred 15+ years of experience in pharmacovigilance and regulatory safety in the biotech or pharmaceutical industry Hands-on experience with FDA and global regulatory authority interactions Proven leadership in overseeing global PV operations and compliance Experience in building and scaling pharmacovigilance processes for commercialization