John Rice

Senior Consultant at Latham BioPharm Group

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.

Before 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.