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Meg Schmierer, PhD
Meg has over a decade of experience in tobacco regulation, including seven years with FDA/CTP and three years with PMI U.S. While with FDA/CTP, she reviewed and supervised reviews of FDA tobacco product applications and, with PMI, she led teams working on the ZYN MRTPAs, from pre-drafting strategy and study development through authorization, including development and implementation of TPSAC strategy.
More about Meg
Meg brings more than a decade of experience in the U.S. tobacco regulatory field, spanning
both government and regulated industry roles. She earned a B.S. in Chemistry from the
College of William & Mary in Williamsburg, Virginia, and a Ph.D. in Chemistry from Arizona
State University. Her doctoral research included the development of a novel delivery
vehicle for a nicotine vaccine.
After earning her Ph.D., Meg spent seven years with the FDA’s Center for Tobacco Products,
where she reviewed new tobacco product applications across all pathways. She
specialized in electronic nicotine delivery systems (ENDS), conducting research, analyzing
scientific literature, and performing premarket tobacco product reviews. She also helped
develop memoranda and reviewer tools for the initial review of premarket tobacco product
applications submitted after September 9, 2020. Before leaving the FDA, Meg served as a
Supervisory Chemist, leading and developing a team of chemistry reviewers, and as a
Technical Project Lead for both the Premarket Tobacco Product Application and Exemption
from Substantial Equivalence programs.
Meg then spent three years in Regulatory Affairs at PMI U.S., specializing in the
development of Modified Risk Tobacco Product Applications (MRTPAs). In this role, she
also developed extensive expertise in preparing both pre- and post-market submissions to
the FDA across all pathways. A key accomplishment was serving as project lead for the
ZYN MRTPAs, guiding the work from pre-submission strategy and study development
through authorization. Her responsibilities also included developing and executing the
strategy for the Tobacco Products Scientific Advisory Committee meeting and leading
related preparation
Meg at home
Meg enjoys staying active and goes bouldering with friends. She also enjoys traveling around the world, particularly when a trip includes a beach or sporting event and is willing to travel long distances for gluten-free fried food. More recently, she has embraced low-stakes crafting and has recently taken up cross-stitch.