Tracy Denison is an experienced Associate Director of CMC Regulatory Affairs at Regeneron, specializing in the review of therapeutic proteins such as monoclonal antibodies and enzymes. With over nine years at the FDA, Tracy provided expertise in CMC submissions, including pre-INDs, INDs, and BLAs. Tracy completed a PhD in Bioengineering at Georgia Tech, focusing on orthopedic cellular biology, and has extensive postdoctoral research experience in cancer drug delivery. Tracy's diverse training includes fellowships in biotechnology and regulatory drug review, highlighting a strong interdisciplinary skill set.
This person is not in the org chart
This person is not in any teams
This person is not in any offices