Job Details

A company is looking for a Regulatory Safety Lead (MD).Key ResponsibilitiesOversee global pharmacovigilance operations, including case management and safety surveillanceRepresent the organization to regulatory authorities and manage safety interactions and inspectionsSupport late-stage development and NDA/BLA submissions, specifically for the 2026 NDA submissionRequired Qualifications and EducationMD required; prior experience as Head of Pharmacovigilance or Global Drug Safety preferred15+ years of experience in pharmacovigilance and regulatory safety in the biotech or pharmaceutical industryHands-on experience with FDA and global regulatory authority interactionsProven leadership in overseeing global PV operations and complianceExperience in building and scaling pharmacovigilance processes for commercialization