Naresh Nayyar, Ph.D., is an experienced regulatory affairs leader with broad experience in clinical/companion diagnostic/CMC and post approval drug development activities. These includes EU MAA, BLA, sNDA (e.g. Herceptin SC, MabThera SC, Rituxan Hycela, HyQvia and Hylenex) approvals including multiple post-approval supplements. Currently he is Associate Vice President of Regulatory and Quality at aTyr Pharma. During his 20+ year career he has worked in small and large pharmaceutical companies, including Agouron, Pfizer, Spectrum, and Halozyme. Naresh Nayyar is experienced in preparing teams for regulatory agency meetings (Pre-IND, Type B/C, EOP2, pre-NDA, and Clarification Meetings), managing interface with agencies, organizing regulatory agency meetings, preparing submissions, and negotiating and interacting with US and international regulatory agencies.