Ivy Lin is a Sr. Regulatory Program Director in Pharma Technical Regulatory at Genentech, A Member of the Roche Group. In this role, Ivy collaborates closely with cross-functional CMC teams on the development of Biologics products, and has led the technical strategy and submissions for post-approval changes and global marketing authorization (ocular products, technology transfer, change in route of administration). Since joining Genentech in 2004, Ivy has developed broad expertise in bioprocessing technologies, injection device and design control, pharmaceutical quality, quality risk management, and CMC team leadership. Ivy received a B.S. degree in Chemical Engineering from the University of California – Davis.