Chief Regulatory and Quality Officer
Sean is a leader in global regulatory affairs with nearly 30 years of experience leading regulatory strategy and product development, predominantly in the field of cell and gene therapy. He is the former senior vice president, head of Global Regulatory Affairs at Freeline Therapeutics, where he led regulatory development from preclinical to clinical, including CMC strategy generation/execution and global agency interface/negotiations/approvals.
Previously, Sean served as senior vice president, head of Regulatory Affairs & Quality Assurance at Axovant (now Sio Gene Therapies), leading all regulatory and quality work for multiple vector-based gene therapy programs and serving as project lead for the lysosomal disease programs. Sean also advanced the regulatory process for multiple cell and gene therapy programs in his roles as vice president, head of Regulatory Affairs and Quality Assurance at Lysogene, senior director of Regulatory Affairs and head of Regulatory CMC at bluebird bio and director, Regulatory Affairs at Sanofi Genzyme.
Sean holds a BS from Boston University.