Speakers

Maria Monroy-Osorio is a Regulatory Health Project Manager in the Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center For Drug Evaluation and Research (CDER) and the FDA. As a regulatory health project manager, Maria provides regulatory project management and coordination in alignment with ORS’s commitments under the GDUFA program, along with project management and coordination for new, innovative technologies and efforts from ORS to increase industry interaction with FDA and streamline staff workload management. Maria also helps spearhead the development, planning, and execution of internal and external workshops held by ORS in conjunction with other FDA offices and organizations. Prior to her role at FDA, Maria served as a project manager in software development for precision medicine initiatives in cancer clinical trials supported by the National Cancer Institute. Maria also has experience in working with medical device manufacturers helping navigate their regulatory and quality affairs. Maria is currently obtaining her Master in Professional Studies in Emergency & Disaster Management from Georgetown University and received her Bachelor of Science in Biomedical Engineering from the University of Virginia.