Maham Ansari

Maham Ansari, MS, RAC, is a seasoned regulatory affairs professional with extensive experience in gene therapy and in vitro diagnostics. Currently serving as Senior Director of Regulatory Affairs at Precision For Medicine, Maham leads the Companion Diagnostic gene therapy program, managing drug-diagnostic co-development projects and spearheading regulatory submissions. Prior roles include Director of Regulatory & Quality at Precision, where responsibilities involved authoring PMAs for complex Class III IVDs, and Director of Regulatory Affairs at Synaptive Medical, focusing on building a regulatory department and executing strategies for various medical devices. Maham's experience also encompasses roles at Focal Healthcare, UnitedHealth Group, and QIAGEN, contributing to drug and device lifecycle management, regulatory submissions, and quality systems development. Maham holds a Master’s degree in Biotechnology/Regulatory Affairs from The Johns Hopkins University and a Bachelor’s degree in Chemical Engineering from the University of Toronto.