Áine Kane is Senior Director at Pfizer UK's Global CMC team with 19 years of regulatory experience. She leads a global team managing submissions for biological, small molecule, and ADC products. With a PhD in Chemistry from Queen’s University Belfast, Áine began her industry career in Analytical R&D. She has long been active in TOPRA, serving in various volunteer and leadership roles, including as President.  Currently she represents Pfizer on the EFPIA biomanufacturing and post-approval change reliance subteams.