Monika Jain

Monika Jain is an accomplished professional with extensive experience in regulatory affairs, particularly in the pharmaceutical and biotechnology sectors. Currently serving as the Director of Regulatory Affairs CMC at Pfizer since April 2022, Monika has also been a member of the USP Expert Committee since 2015, contributing to the Chemical Monograph Committee focused on antibiotics, antiviral, and antimicrobial drug substances and products. Prior to Pfizer, Monika held key positions at PPD, Mylan, and Laboratoire de Biologie Moléculaire et Cellulaire du Cancer, building a strong foundation in regulatory CMC consultancy and research. Monika began a career in the pharmaceutical industry at Sun Pharmaceutical Industries Ltd as a Regulatory/Research Scientist and started as an Analyst at Lupin. Academic credentials include a Doctor of Philosophy in Analytical Chemistry from BU India, obtained between 2005 and 2009.