Ashley Smith

Ashley Smith is an accomplished professional in regulatory affairs with extensive experience in the biopharmaceutical industry. Currently serving as Senior Manager of Regulatory Affairs at Generate Biomedicines since April 2024, Ashley previously held the position of Regulatory Affairs Manager at Thermo Fisher Scientific from June 2021 to October 2023. With a strong background in biologics and Chemistry, Manufacturing, and Controls (CMC), Ashley also worked as a Senior Regulatory Affairs Associate at Marker Therapeutics, Inc. and as a Senior Regulatory Affairs Specialist at Molecular Templates. Experience includes a role as a Staff Fellow at the U.S. Department of Health and Human Services and an ORISE Postdoctoral Fellowship at the FDA. Ashley earned a Ph.D. in Microbiology/Immunology from UNT Health Science Center and a Bachelor of Science in Biomedical Sciences from Texas A&M University-Corpus Christi.