Tanya Scharton-Kersten is a scientist and Global Regulatory Affairs Professional (20+ years and RAC). She has a PhD in Immunology; experience with bacterial, metabolic, neurologic and viral disease prevention and treatment. Focused on innovative biologics, gene therapies, and vaccines. Motivated by developing AND implementing global regulatory strategies for novel and emerging platform technologies. Engaged, get things done, risk-based decision maker and ‘doer’ for complex CMC projects.