Michelle Wells, MS, RAC
VP, Regulatory Affairs
Michelle’s 30 years of experience in regulatory, quality and clinical spans across small molecule therapeutics, medical devices and biologics. She brings the full life cycle of pre- and post-marketing strategic planning, quality systems development logistics, and clinical management experience to her role at Frequency.
Michelle has brought novel products to market for use in respiratory therapy, dermatology, rare diseases and pain management. Her most recent experience includes work in gene editing and gene therapy as well as human cell and tissue products. She has extensive experience working with the FDA across CBER, CDER and CDRH, and with regulatory authorities in Europe.
Michelle has also developed curriculum and provided instruction in Regulatory Affairs, Chemistry Manufacturing and Controls, and Clinical Trial Design at Keck Graduate Institute at the Claremont Colleges in Claremont, California. She earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and her master’s degree in Clinical Research and Regulatory Affairs from Arizona State University. She also completed the RAPS Executive Development Program at Kellogg School of Management.