Matthew Fitzpatrick has over twelve years of regulatory operation experience in large pharmaceutical, biotech, and the contract research organization (CRO) industry. Mr. Fitzpatrick is skillfully experienced in compiling submissions using the electronic common technical document (eCTD) format for a range of regulatory submissions, including INDs and amendments, NDAs and supplements, Biologics License Applications (BLAs), pre-IND and NDA meeting requests and packages. Prior to joining Latham, Mr. Fitzpatrick was a Regulatory Operations Manager, Pearl Therapeutics, where he successfully managed the regulatory submission process, from the Investigational New Drug (IND) Application, through Phase III clinical trials, to the submission of the New Drug Application (NDA) for the approved respiratory product Bevepsi Aerosphere®. This encompassed planning and tracking of all the quality control (QC) activities related to final submission documents. Beginning with the regulatory filing of the IND application to the Food and Drug Administration (FDA) along with all subsequent IND amendments. Served as regulatory lead for the review and approval of Phase III clinical site documents, ensuring drug could be shipped to these approved sites. In support of the NDA submission, he handled the project tracking and coordination of the final QC review of all documents. Mr. Fitzpatrick served on a task force at GlaxoSmithKline to refine and improve the regulatory authoring process and streamline workflow. He handled the authoring of the validation documentation for the electronic publishing software upgrades. At Cato Research, Mr. Fitzpatrick managed the budgeting, selection, and implementation of new publishing software including Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs), for the compliance of electronic applications.
Mr. Fitzpatrick earned a Bachelor of Science degree in Human Services from Springfield College.