Mr. Rice has nearly 15 years of experience in Regulatory Operations, including biologics, pharmaceuticals, and medical devices. He has led the production and lifecycle management of numerous eCTD-based investigational and marketing applications. In addition, he is a subject matter expert (SME) in electronic submissions and regulatory data formats and requirements with in-depth knowledge of standards from organizations, such as ICH, HL7, and CDISC.
As a Senior Consultant at LBG, Mr. Rice serves as a regulatory submissions data standards SME. His responsibilities include project management for regulatory submissions production as well as publishing, reviewing, and submitting eCTD-based regulatory filings. He is also a point of contact for technical issues related to regulatory submissions.
Mr. Rice has worked with large and small industry sponsors and nonprofit organizations, such as the USP. He recently helped a company bootstrap a regulatory operations function and successfully navigate simultaneous multi-region applications.
Prior to his career in the life sciences industry, Mr. Rice consulted with various firms on the development of standards-based solutions for the representation of complex information architectures. He helped design and build custom knowledge management solutions and helped companies create smart, practical information management processes.
Mr. Rice holds a B.A. in Philosophy from Washington University in Saint Louis.
