Sarah_Pope Miksinski

Sarah C. Pope Miksinski PhD

Senior Director in Regulatory CMC, AstraZeneca

Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently a Senior Director in Regulatory CMC, AstraZeneca. Her duties include leadership of a global team covering CMC regulatory strategy for development and pre-approval 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 and serving as chair of ISPE’s Regulatory Steering Council. At the time of her departure from FDA, she was the head of two offices in FDA’s Office of Pharmaceutical Quality – serving permanently as the director of the Office of New Drug Products (2014-2018) and simultaneously serving as the interim director of the Office of Surveillance (2016-2017). Sarah began her FDA career in 2002 and served as a primary, secondary and tertiary reviewer before being selected as a senior management official. 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).