Teresa Oblak, PhD
Executive Director, Clinical Regulatory Strategy & Head of Nonclinical Regulatory Writing
Teresa Oblak, PhD is an Executive Director in Regulatory Strategy Consulting at Fortrea, based in Michigan, where she focuses on clinical regulatory strategy to support global development programs and key regulatory milestones. She has nearly 20 years of drug development experience across regulatory affairs, medical writing, publication planning, and value demonstration.
Teresa regularly supports U.S. IND development, responses to clinical and non-hold issues, expedited program applications, special protocol assessments, pediatric plans, and diversity action plans. She has led FDA and EMA interactions across multiple therapeutic areas, including rare and orphan diseases, spanning small molecules, biologics, biosimilars, and combination products. She also serves as Head of Nonclinical Regulatory Writing.
Before Fortrea, Teresa was a scientific director and lead writer at a medical communications agency. She holds a PhD in Chemistry from Michigan State University and a BS in Chemistry from the University of Michigan–Dearborn.