Roy Alston

Roy Alston is a highly experienced professional in regulatory affairs and quality assurance, currently serving as the Sr. Director of Regulatory CMC at Aerogen Pharma since September 2025. Prior roles include Director of CMC Regulatory Affairs at Sarepta Therapeutics and Associate Director positions at Vertex Pharmaceuticals and Takeda, where contributions included leading regulatory CMC activities and supporting global marketing registrations. Alston's extensive background began at Biogen, where considerable expertise was developed as a Senior Manager in Product Development Quality and as a Scientist, managing drug product validation, formulation development, and regulatory submissions. Alston holds a Ph.D. and a master's degree in Biochemistry from Texas A&M University, as well as a Bachelor of Science in Education from the University of Arkansas.