About

Ron Lang is a highly experienced Vice President of Regulatory Affairs and Quality Assurance at Molecular Biologicals, with over 35 years of experience in the industry. He has a strong background in R&D, clinical study management, and auditing activities, as well as skills in manufacturing transfer, GCPs, GMPs, and ICH guidelines. Ron also has experience in continuous process improvement, analytical method validation, FDA, EMEA, and Health Canada audit interactions, CAPA development, and implementation, DEA regulations, product stability and release requirements, project management, and managing technical staff. Ron's career also includes extensive BD experience, with over 20 closed deals and a valuation in excess of $20B. He has a Ph.D. in Analytical Chemistry from the University of Georgia, School of Pharmacy, an M.S. from the University of Georgia, School of Pharmacy, and a B.A. in Chemistry from Emory University. In his current role at Molecular Biologicals, Ron participates in regulatory interactions and communications with the FDA, oversees submissions with the FDA, and serves as a subject matter expert in both regulatory and quality areas. He ensures that the Quality Management System is maintained and meets system specifications and participates in FDA audits and inspections. Previously, Ron served as Head of Clinical, Regulatory & Quality Operations at Essential Pharmaceuticals, LLC, where he gained experience with medical devices, prepared 510Ks and DeNovo submissions, and had direct interactions with the FDA. He also worked as a Business Development Consultant at Intas Pharmaceuticals - Accord Healthcare, where he identified new assets to acquire to expand the product portfolio and participated in the due diligence process to evaluate new assets. Ron has a strong tech stack, including QA and software engineering skills. Overall, Ron is a highly accomplished and experienced regulatory and quality professional with a proven track record of success in the industry.