Vassia Tegoulia is a Regulatory Advisor and Group Leader in Technical Regulatory - Development Biologics at Genentech. She has worked in Regulatory since 2008 on US and International regulatory projects, regulatory strategy and QbD and she has been a CMC team leader for a monoclonal antibody in development. Before Regulatory, she spent for 8 years in the Process Development organization at Genentech where she was responsible for purification process development and technology transfers. She has participated in the QbD implementation effort for large molecules at Genentech since 2008, working on the FDA QbD Pilot Program and on interactions with other Health Authorities. She is currently the Technical Regulatory team leader responsible for the first biologic QbD Marketing Authorization Application at Genentech/Roche. Vassia received her Diploma in chemical engineering from the Aristotle University in Greece and her PhD in chemical engineering from the University of Delaware.