Olivier Dirat

Olivier Dirat

Senior Director – Global Regulatory Sciences

Pfizer

Olivier Dirat completed his PhD in organic chemistry at Paris University, followed by a post-doctoral position at Stanford University. Olivier has over 20 years of industrial experience in discovery and late-stage API process development at Merck and Pfizer and currently holds the position of Senior Director within Pfizer Global Regulatory Sciences CMC Advisory Office where he provides technical and regulatory guidance and direction to teams on a wide array of topics, including CMC regulatory strategies, the development and articulation of control strategies, impurities management, N-nitrosamines, continuous manufacturing, starting materials, ADCs, mRNA vaccine lipids and other special cases. He also leads a CMC team focussing on post approval marketed products. He chairs one of Pfizer’s Impurities Councils, a multidisciplinary council that provides advice to teams regarding impurities (including nitrosamines) from safety, quality and regulatory perspectives. External to Pfizer, Olivier is involved with ICH as co-rapporteur for ICH Q6 EWG (PhRMA) and deputy topic lead for ICH Q13 IWG (PhRMA), IQ consortium Board of Directors, and also on N-Nitrosamines, Starting Materials, ADCs, Co-processed APIs, Novel Excipients and EFPIA MQEG CMC team and on N-Nitrosamines, ICH M7, and ICH Q6. Olivier is based in Sandwich, UK.