Maryland Licensed Regulatory Safety Lead

Job Summary

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