Marie Parrish
About Marie Parrish
Marie Parrish serves as the Senior Director of Regulatory CMC Strategy at Roivant Sciences, where she has worked since 2021. With a robust background in regulatory affairs and a Ph.D. in Pharmaceutical Analysis, she has held various leadership roles in the pharmaceutical industry over two decades.
Work at Roivant Sciences
Marie Parrish has been serving as the Senior Director of Regulatory CMC Strategy at Roivant Sciences since 2021. In this role, she is responsible for overseeing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC). Based in New York, New York, she has contributed to the company's efforts in advancing drug development and regulatory compliance.
Previous Roles in Regulatory Affairs
Prior to her current position, Marie Parrish held several significant roles in regulatory affairs. She was the CMC Topic Group Chair at IRISS Forum from 2017 to 2023. She also worked at Sun Pharma Advanced Research Company Ltd. as Director of Regulatory Affairs Strategy from 2020 to 2021, and at Glenmark Pharmaceuticals as Director of Regulatory Affairs - Innovative Pharmaceuticals from 2016 to 2019. Her extensive experience includes positions at ImClone Systems, sanofi-aventis, Pfizer, and Warner Lambert/Parke Davis.
Education and Expertise
Marie Parrish holds a B.S. in Chemistry from the University of the Sciences in Philadelphia and a Ph.D. in Pharmaceutical Analysis from Rutgers, The State University of New Jersey-New Brunswick. She possesses a strong scientific foundation and has extensive experience managing cross-functional teams throughout the drug development process, from Phase I through post New Drug Application (NDA).
Regulatory Submissions and CMC Management
Marie Parrish has expertise in analytical development activities, particularly regarding CMC content for global regulatory submissions. She has a proven background in handling both small and large molecule registration submissions. Her focus on quality and current Good Manufacturing Practices (cGMP) issues is integral to her approach in regulatory submissions.
Career Timeline
Marie Parrish's career spans over two decades in the pharmaceutical industry. She began her career as a Research Investigator at Warner Lambert/Parke Davis in 1992 and has since held various roles, including Manager of CMC Documentation and Associate Director positions at sanofi-aventis. Her career trajectory illustrates her progression through increasing responsibilities in regulatory affairs and CMC strategy.