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