Motivated, high performing leader in Regulatory CMC Advisory Office and impurities management advising teams on small molecule matters relating to control strategies (ICH Q6 EWG), manufacture, continuous manufacturing (ICH Q13 IWG), impurities management, N-nitrosamines, starting materials, ADCs, mRNA vaccine lipids and other special cases. The Pfizer Regulatory CMC Advisory Office is a collection of global Pfizer technical and regulatory experts that provide guidance & direction to project teams to mitigate regulatory risk & integrate CMC policy with product strategies; while developing and advocating policy positions (internally and externally). Highly effective and collaborative advisor, with experience in CMC regulatory strategies, impurities management and late stage development projects for API’s (P2b to commercialization and post approval). 22 years in big pharma (Pfizer process and Merck medchem) with consistent high performance. Successfully launched and registered Dacomitinib, Talazoparib, Comirnaty, Paxlovid and advised many other teams throughout development and registration. Chairs one of Pfizer’s Impurities Councils, a multidisciplinary council that provides advice to teams regarding impurities from safety, quality and regulatory perspectives. Co-rapporteur for ICH Q6 EWG representing PhRMA and deputy topic lead for ICH Q13 IWG. IQ consortium: Board of Directors, N-nitrosamines, starting materials, ADCs IQ working groups. EFPIA: MQEG CMC team, N-nitrosamines, ICH M7, and ICH Q6. Regular conference speaker, author of >30 publications and 3 patents.Specialties: ICH Q6, ICH Q13, Control strategy, N-nitrosamines, CMC Regulatory strategies, Regulatory filings, Impurities management, Genotoxic Impurities, People management, Chemical R&D, Process chemistry, Starting materials, API, Late stage development, Quality by Design (QbD), Bilingual French-English