| Rita Algorri, PhD is a Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, her responsibilities include leading and orchestrating internal and external engagement activities relating to regulatory modernization, digitization, automation, and emerging technologies. As part of this work, Rita is the Product Team Lead for the CMC Data Exchange platform currently under development by Accumulus Synergy, a non-profit company founded in 2020 which seeks to advance innovative solutions that can reduce regulatory review times and transform global data exchange. Rita leads interactions between Health Authorities and Accumulus, provides key expertise and guidance on the Accumulus platform’s features and design, and co-created an integrated CMC Content Model that will enable the platform’s usage of data standards and controlled terminologies. Rita also serves within Amgen’s Advocacy and External Engagement function which fosters collaboration with multiple cross-functional teams to coordinate and progress company and industry initiatives. She is an active member of multiple external organizations and industry groups, with particular focus on supporting CMC acceleration and implementation of regulatory technologies. She has co-authored and led the development of multiple peer-reviewed articles on regulatory topics such as structured content management, agile manufacturing, regulatory acceleration, and others. Prior to her current role, Rita supported global filing activities conducted within Global Regulatory Affairs Oncology at Amgen. She is a microbiologist by training and holds a PhD in Clinical and Experimental Therapeutics and M.S. in Regulatory Science from the University of Southern California School of Pharmacy. |