Shell Sims

Shell Sims is a quality-focused regulatory affairs professional with extensive experience in regulatory management across the pharmaceutical, medical device, and biotechnology industries. They hold a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University and are currently pursuing a Bachelor of Arts in Organizational Management and a Bachelor of Science in Biology. Shell's career includes significant roles at Gilead Sciences, Bayer HealthCare, and Amgen, where they have developed regulatory strategies, managed quality systems, and facilitated compliance with FDA standards. Currently, they serve as a Senior Manager for QA External Biologics, providing oversight for analytical testing activities in clinical and commercial programs.