Joan brings 18 years of experience from the pharmaceutical industry to Critical Path Services, guiding our clients through the U.S. and international regulatory submission processes. As a Dossier Coordinator, she works with project teams to prepare complex, technical dossiers for regulatory submission to agencies worldwide. Her expertise includes management of projects involving cross-functional teams and addresses issues such as change control and electronic document publishing to achieve and maintain compliance with FDA quality system regulations.

Joan spent several years as a laboratory technician, testing drug substance and finished products. Then, after developing and implementing a sample-tracking system, Joan moved into Scientific Regulatory Affairs at DuPont Pharmaceuticals / Bristol Myers Squibb Pharma. Here, her work focused on defining global Chemistry Manufacturing and Controls (CMC) registration strategies and developing the appropriate documentation. Joan's CMC experience covers documents supporting NDAs, sNDAs, MAAs, NDSs, ANDAs, INDs, INDSs, and CTXs.

Joan graduated from Delaware Technical & Community College with an Associate Degree in applied science/bioscience.