Meriem Gaval Cruz, PhD

Meriem Gaval Cruz, PhD

Associate Director, Regulatory Affairs

Dr. Gaval Cruz has six years of experience conducting strategic reviews of translational and clinical research programs as well as product development programs and making R&D and regulatory recommendations. She has regulatory affairs experience in the US and Europe with a focus on pre-IND, first-in-human programs in orphan diseases. Dr. Gaval Cruz has authored over 40 regulatory submissions to the FDA and EMA including briefing packages, INDs, breakthrough therapy designations, and orphan designations. She is an experienced project manager and has previously facilitated and managed academic-industry collaborative partnerships. Dr. Gaval Cruz holds Bachelor of Science degrees in Biology and Psychology from Florida State University and earned her doctorate in Neuroscience from Emory University. She was a postdoctoral fellow at the University of Maryland Medical Center and the National Institute on Drug Abuse. Her research focused on the role of catecholamines in psychiatric disorders.