77th Tobacco Science Research Conference

September 8-11, 2024Atlanta, Georgia USA

Lillian Ortega

Lillian Ortega joined Chemular Inc. in January 2023, taking on a pivotal consulting role where she leverages her extensive expertise to guide businesses through the complexities of FDA regulatory processes. Prior to joining Chemular, Lillian had a distinguished thirteen-year career at the Food and Drug Administration, where she excelled in leading strategic and complex compliance and regulatory projects . Her deep-rooted experience in FDA regulatory processes is both extensive and current, covering a broad range of sectors including tobacco products, biologics, and FDA-regulated clinical research. Before becoming a Regulatory Consultant, she served as the Director of Enforcement and Manufacturing at the FDA’s Center for Tobacco Products. In this role, she was responsible for a wide array of critical functions, such as leading manufacturer compliance and enforcement programs, directing manufacturer inspection activities, overseeing compliance actions, coordinating tobacco recall operations, and managing import activities. Lillian’s academic foundation in Microbiology and Public Health Policy complements her professional experience, enabling her to provide invaluable insights. Her unique blend of regulatory oversight and business guidance empowers organizations to navigate the FDA regulatory landscape successfully. Her consulting services are designed to position products and operations for optimal success in a highly regulated environment.