Michele Obert U.S. FDA

Michele Obert is a Pre-Approval Manager and Drug Specialist currently working FDA’s Office of Regulatory Affairs (ORA) in the Office of Pharmaceutical Quality Operations Division III. As a Pre-Approval Manager, Michele supports the review of human and veterinary drug applications. She also participates in foreign and domestic pharmaceutical inspections. In 2009, she became a member of the inaugural Dedicated Foreign Drug Cadre, performing numerous foreign inspections in Europe and Asia. She began her role as an ORA Pre-Approval Manager in 2015. In addition, Michele is an active member of the FDA Pharmaceutical Training Cadre, where she is able to impart her 30 plus years of FDA experience to assist with the education and training of FDA Investigators. She graduated from Wayne State College in Wayne, Nebraska with a major in Chemistry and minor in Physics.