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avatar for Nina Cauchon

Nina Cauchon

Amgen
Director Regulatory Affairs CMC
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. She is chair of the AAPS CMC Community, and is also active in ISPE, CASSS/WCBP, and PQRI. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies, CMC aspects of expedited review pathways, regulatory harmonization, and science and risk-based approaches to regulations. She sits on the ICH Q2(R2)/Q14 Expert Working Group for Analytical Procedure Development and Validation as the PhRMA Deputy Topic Lead.