Michele Obert, Drug Specialist and Pre-Approval Manager Office of Medical Products and Tobacco Operations (OMPTO), Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA)
My name is Michele Obert and I am a Drug Specialist and Pre-Approval Manager in the Office of Regulatory Affairs (ORA). I have spent my 29-year career at FDA/ORA ensuring that the pharmaceuticals the public uses are safe and effective and manufactured in accordance with the law. I travel both domestically and overseas — to places such as South Africa, India, China, Singapore, and Iceland — to conduct inspections of drug manufacturing and processing facilities.
I also review and assess applications submitted by pharmaceutical companies seeking approval to produce and market new drugs. I make recommendations on such approvals, working together with drug experts and researchers serving on committees of the FDA Center for Drug Evaluation and Research. I am involved in foreign inspections, which prevent the importation into the United States of drug ingredients that may be in violation of FDA laws and regulations. I am also involved in numerous inspections whose results affect recommendations to approve/reject new consumer products that companies want to introduce into the market.
I began my career as a chemist in the Kansas City District Laboratory. Shortly after, I began conducting drug inspections at pharmaceutical labs and performing analyses on various FDA-regulated products. Over time, my analyses became focused on drugs, and, eventually, I attained Level-1 Investigator Certification. I was one of the few people at that time who was an analyst and could also perform independent inspections. This was a big help for the inspection branch as they didn’t have to send out someone else to do team inspections with me.
Today, I train the next generation of inspectors and speak at various venues throughout the world and within the FDA. I educate audiences on matters such as performing inspections, maintaining professionalism, and keeping up-to-date on pharmaceutical topics. I love knowing that the work I do every day has an impact on protecting consumers, my family, and friends. My colleagues and supervisors share the same pride in the work, and we are enthusiastic about our service to the American public. I am proud to be this year’s ORA Investigator of the Year.
I am Michele Obert, and I am ORA.