Nina S. Cauchon, PhD is Director Regulatory Affairs CMC at Amgen Inc in Thousand Oaks, CA, and leads RA-CMC Advocacy and External Engagement. In this role, she is responsible for developing cross- product Regulatory Affairs - CMC policies with interfaces to Process Development, Operations, and Quality, and provides input on company external initiatives as well as product-specific regulatory strategies. Her areas of interest include regulatory CMC challenges for innovative modalities, emerging technologies, expedited review pathways, regulatory harmonization, and science and risk-based approaches to regulations. Nina has over 25 years of industry experience with all phases of drug development, including both small molecules and biologics, and prior to her current role she was a director leading Analytical Development within Pharmaceutics/Process Development. She holds a PhD in Medicinal Chemistry from the Purdue University School of Pharmacy, and a RAC certification.
Nina is a member of the current ISPE PQLI ICH Q12 Team and the previous ISPE PQLI Accelerated Medicinal Products Team. She has been session chair/speaker at multiple ISPE conferences and has published in Pharm. Eng. Magazine. Nina is active in several external organizations which provide a strong network and knowledge base, including being a speaker/committee member for CASSS, PQRI, AAPS, IQ, and DIA. She is a PhRMA Global Quality and Manufacturing group member and sits on the ICH Q2(R2)/Q14 Expert Working Group. She is also involved with teaching activities, having taught lectures at USC, UCSB, Cal State-Channel Islands, and Purdue University.