Alexandra Beumer Sassi | Executive Director, CMC Regulatory Affairs
AstraZeneca

Alexandra Beumer Sassi, PharmD, PhD, RAC is an accomplished leader with over 24 years of experience in the biopharmaceutical and consulting industries. She currently serves as Executive Director of Chemistry, Manufacturing, and Controls (CMC) Regulatory at AstraZeneca, where she oversees the biologics, cell, and gene therapy portfolio for oncology. In this role, Dr. Beumer Sassi provides strategic leadership, technical expertise, and regulatory guidance. Before joining AstraZeneca, Dr. Beumer Sassi was the Global Head of CMC & Quality at Voisin Consulting Life Sciences (VCLS). As a trusted advisor to biotech and pharmaceutical companies, she led cross-functional initiatives to help clients achieve key investor milestones and advance portfolios from pre-clinical development to marketing authorization. Her expertise centers on the development of biologics, cell, and gene therapies, with a focus on ensuring product quality, efficacy, safety, and compliance. Dr. Beumer Sassi held multiple positions with growing responsibilities at GlaxoSmithKline working on monoclonal antibodies, formulation development, characterization and tech transfer.  Dr. Beumer Sassi’s robust scientific foundation is supported by a PhD and post-doctoral training in Pharmaceutical Sciences, complemented by extensive industry and consulting experience. She has played a pivotal role in the development and commercialization of over 50 innovative products, successfully guiding them through clinical milestones and regulatory approvals. She earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh, where her dissertation focused on pre-clinical protein characterization and formulation development of biopharmaceutical microbicides. She also holds a Pharmacy degree from the University of São Paulo, Brazil, and completed post-doctoral research at the Magee-Womens Research Institute in Pittsburgh. Dr. Beumer Sassi has authored numerous peer-reviewed publications and book chapters and has been a frequent speaker, organizer, and chair at national and international conferences. In addition to her academic and professional achievements, Dr. Beumer Sassi holds a US Regulatory Affairs Certification (RAC) and has completed executive leadership training through the eMAPS program. She is an active member of several professional organizations, including the Alliance for Regenerative Medicine (ARM), the Regulatory Affairs Professional Society (RAPS), the Cell and Gene Therapy Scientific Committee at CASSS, BIO International, and Women in Bio.