Joseph Kutza


Dr. Kutza joined MedImmune in February 2007 and is currently Senior Director and Group Manager in the Post-Approval Biologics Strategy Team in Regulatory Affairs – CMC. This team is responsible for post-approval regulatory submissions, marketing applications to global markets, and regulatory support for AZ biologics manufacturing sites. Dr. Kutza is active in several professional societies and currently serves on a USP Expert Panel and is a member of the CASSS Board of Directors. Before joining AstraZeneca, Dr. Kutza was a product reviewer and Team Leader in the Regulatory Science and Policy Branch of the Division of Monoclonal Antibodies responsible for product review of INDs, BLAs, and related amendments and supplements for monoclonal antibody products, development of agency-wide regulatory policy, and regularly participating in both pre-approval and biennial GMP inspections as a product specialist.