Loretta E. Chi

Loretta E. Chi serves as an Adjunct Professor at Johns Hopkins University since 2010, teaching Food and Drug Law through the Center for Biotechnology Education. Concurrently, she holds the position of Senior Regulatory Counsel at the U.S. Food and Drug Administration (FDA) within the Center for Tobacco Products, where she provides legal guidance to the Office of Compliance and Enforcement since November 2012.

Her educational foundation includes a Juris Doctor (J.D.) from George Washington University Law School in Washington, D.C. Professional credentials encompass membership in the Maryland and District of Columbia bars alongside Project Management Professional (PMP) certification.

Ms. Chi's academic expertise centers on regulatory frameworks governing biotechnology and life sciences, drawing from 15+ years as a life sciences entrepreneur and decade-long legal career specializing in FDA compliance. Key research domains include Biotechnology Regulation, Pharmaceutical Compliance, Tobacco Product Enforcement, Corporate Legal Strategy, and Government Relations. Her industry experience bridges theoretical instruction with real-world regulatory challenges in biotech commercialization.

As a certified Project Management Professional (PMP), she integrates structured project execution methodologies into regulatory compliance workflows. Her dual-government-academic role uniquely positions her to translate complex FDA enforcement mechanisms into educational contexts for biotechnology graduate students.