Olga Braem

Director, Global Regulatory Affairs CMC at Kyowo Kirin

Speaker

Dr. Olga Braem is a Regulatory Affairs–CMC expert with more than 20 years of experience in the pharmaceutical industry across Regulatory Affairs and Drug Development. Over the past nine years, she has led CMC regulatory strategy for biologics, small-molecule, and combination products—including INDs/IMPDs and BLAs/NDAs/MAAs/NDSs—contributing to two U.S. drug approvals within two years. A recognized subject matter expert in biologics, bioanalytical science, and formulation development, Olga has led successful global Health Authority interactions across North America, EMEA, and Asia-Pacific regions, providing strategic regulatory guidance to teams worldwide.