Earl Dye is Director of Technical Regulatory Policy in Genentech’s Washington, DC Regulatory Affairs Office, and is the FDA Liaison for a Roche Global Technical Regulatory Policy Group. He has been at Genentech for eleven years and is responsible for evaluating proposed biotechnology/biologic CMC regulations, guidelines, policies and practices of US FDA and other federal government agencies. In this role he is responsible for developing strategic relationships with FDA, BIO, USP and other interested parties to shape the outcome of final guidance. Dr. Dye is also actively involved in training technical staff on new and existing guidance, and working with staff and project teams to provide technical and regulatory advice on submissions to ensure they address Genentech/Roche needs and potential health authority concerns. Dr. Dye has spoken at many conferences in the US and internationally including DIA, BIO, ISPE, PDA, RAPS, Sinduspharma in Brasil, and at CASSS CMC Strategy Forums in the US, Europe, and Tokyo.