Vice President, Regulatory Affairs
Naomi Kautz brings 20 years of multidisciplinary experience in the biotechnology and pharmaceutical industries to the Premier Consulting regulatory affairs team. She has focused on regulatory affairs, research and development, and policy since completing her academic training in biochemistry. Her 15-year tenure in regulatory affairs has spanned development from early through late stage, including new drug application filings. She has also served as U.S. regulatory lead and global regulatory lead on late-stage programs, and since 2009 has focused on regulatory affairs related to the development of cell and gene therapy. Ms. Kautz has worked on several programs with immuno-oncology agents, including chimeric antigen receptor T-cell therapies, as well as cell and gene therapies for neurodegenerative conditions. She has a bachelor’s degree from the University of Guelph and a master’s from Queen’s University.