About me
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche, Cecilia served for over 12 years in the Office of Biotechnology Products (OBP) in CDER, US FDA, where she held positions of increasing responsibilities performing and then overseeing CMC/product quality assessments of regulatory submissions at all phases of development. Cecilia is active in several expert groups in PhRMA and BIO trade associations and is part of the ICH Expert Working Group revising the specifications guideline.
