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Monique Carter

Meet Monique Carter, the November featured Science Sista of the month! Monique Carter has over 20 years of basic science research, clinical research, strategic consulting, and drug product development experience. She is currently a Senior Director and Global Regulatory Strategy Lead at Pfizer, Inc. in Global Regulatory Affairs (GRA) – Internal Medicine, within Global Product Development. At Pfizer, she leads innovative and adaptive development strategies ranging from the early investigational space through post-marketing approval to fill unmet needs for patients living with chronic conditions.

Monique is passionate about leading teams and initiatives focused on building and maintaining a diverse industry regulatory science talent pipeline. She recently led the initiation of the inaugural Pfizer GRA – Historically Black College/University (HBCU) College of Pharmacy (COP) Advanced Pharmacy Practice Experience (APPE) preceptorship pilot program in collaboration with Howard University COP. The pilot program experience is detailed in a manuscript entitled ‘Fostering Diversity and Talent: A Pfizer Case Study’, in which Carter is the first author, published in Regulatory Focus, the flagship publication of the Regulatory Affairs Professionals Society (RAPS). This successful pilot program is actively being expanded to include all HBCU COPs nationwide. Additionally, feasibility is being assessed to support potential global expansion.

Before joining Pfizer, Inc., Monique worked as a cross-functional regulatory and clinical development strategy team leader across the drug development continuum spanning a host of therapeutic areas in global biotechnology investment firms and management consulting settings. Carter is an appointed member of the Regulatory Affairs Professionals Society (RAPS) Regulatory Focus Editorial Advisory Committee (EAC) and a member of The Organisation for Professionals in Regulatory Affairs (TOPRA) Product Information Steering Committee. She holds the Regulatory Affairs Certification (RAC) as well as formal STEM and drug development training from Baylor University, Johns Hopkins University, the University of Southern California.


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