Carmen Betancourt-Riche began her career in 1977 at Cutter Laboratories (Bayer) as a research associate in microbiology and physiology. After 10 years, she joined Cutter’s international Regulatory Affairs department supporting the company’s commercial portfolio of biologics, including supporting the preparation of a Biologics License Application (BLA) for its first recombinant product, Kogenate®, for hemophilia A. In 1992 she joined the newly formed department for international Regulatory Affairs at Genentech, where she supported their clinical stage HIV vaccine program as well as the clinical development and EU marketing applications for Pulmozyme® (dornase alfa), Herceptin® (tratuzumab), and Rituxan® (rituximab).

After leaving Genentech in 2001, Carmen took regulatory affairs and executive positions at several smaller pharmaceutical companies in the areas of infectious disease and oncology. In addition to Regulatory Affairs, her responsibilities included managerial oversight for Quality Assurance, Quality Control, and Project Management. Programs in which she participated include tositumomab (Bexxar®, Coulter Pharmaceutical), ceftaroline fosamil (Teflaro®, Cerexa Pharmaceuticals), elosufase apha (Vimizim®, BioMarin Pharmaceutical), and rezafungin (Rezzayo®, Cidara Therapeutics)—approved by the FDA in 2023 for the treatment of candidemia and invasive candidiasis. Carmen also worked on VaxGen’s antiviral (HIV) and recombinant anthrax vaccine programs, Sangart’s PEGylated human blood protein development program, and KaloBios Pharmaceuticals’ PEGylated antibody fragment development program for infections due to Pseudomonas aeruginosa.

Carmen’s experience includes obtaining designations for orphan drugs, expedited development designations for qualified infectious disease product (QIDP), and Fast Track. Carmen earned her Bachelor of Science degree in Biological Sciences from the University of California, Davis in 1973 and her MBA in International Corporate Management from Golden Gate University in 1991.