Brooke Higgins

Brooke K. Higgins is a Senior Vice President for Regulatory Compliance at Eliquent Life Sciences. In this role, she provides strategic guidance on issues related to drug product manufacturing, quality, and regulatory compliance and supports clients as they achieve their quality goals. Prior to joining Eliquent, she served 23 years with FDA, working in both the field and at the Center for Drug Evaluation and Research (CDER). Ms. Higgins spent 11 years with the Office of Manufacturing Quality at CDER, where she held roles of increasing responsibility, including Senior Policy Advisor, Acting Team Lead and Branch Chief. She was responsible for reviewing both international and domestic cases, supporting regulatory and enforcement actions, and providing training to investigators, analysts, reviewers, and compliance officers. Prior to joining CDER, Ms. Higgins spent 12 years with the Office of Inspections and Investigations (formerly ORA), where she began her career as an Investigator and later advanced to serve as a Pre-Approval Manager. While working as the Pre-Approval Manager, she continued leading domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a MS in Food Science, focusing on food microbiology, and a BS in Biology from Virginia Tech.