Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently a Executive Director in CMC Regulatory Affairs. Her duties include leadership of a global team covering CMC regulatory strategy (development and lifecycle) for health authority submissions, as well as serving as a key contributor to several ongoing initiatives including continuous manufacturing and Q12 implementation. She represents AstraZeneca in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s Regulatory Steering Council, and supporting multiple other advocacy efforts (review/inspection standards, nitrosamines, PDUFA, and KASA). In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2).
Previously, Sarah served a lengthy tenure at FDA, lasting from 2002-2018, where she and served as a primary, secondary, and tertiary reviewer before being selected (2009) as a senior management official. She held multiple leadership roles in CDER’s Office of Pharmaceutical Quality, where she contributed heavily to many ongoing strategic and advocacy initiatives across the assessment and inspectional spaces.
Prior to joining FDA, she completed a postdoctoral fellowship at the National Institute of Health. She is trained as an organic chemist and possesses a PhD in organic chemistry (Oklahoma State University, 1999). She also has a B.A. in chemistry (Earlham College, 1994).
