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This Scientist's Life: Monique Carter

Meet Monique Carter, a regulatory scientist at Pfizer in Collegeville, PA, who works to support the translation of molecules to potential medicines.

Monique Carter, Director Worldwide Regulatory Strategy, is a pro at identifying potential bumps in the road to getting medicines to patients, and for navigating those bumps.

Monique has always thought like a scientist, even before she knew she wanted to be one. During a pre-college summer internship with the NIH, in which her team worked on large-scale mapping of genetic mutations to learn more about proliferative diseases, “I was skeptical,” she said. “While I had a great experience, I wasn’t sure that ‘big science’ approaches would readily impact bench-level research.”

But, like a true scientist, she was willing to prove herself wrong if she had the data to do so. After listening to a podcast on sequencing the human genome, she said, “I decided that maybe a science-focused career was the right fit.” As the story of the genome-sequencing efforts of industry and the government unfolded, my curiosity was piqued. There was no way that I could not be involved with a field that made what I had thought impossible a reality.” That was during her first semester in college. By the end of her senior year, she became the first person in her family to become a graduate with a science degree, in biochemistry and physics. She then went on to complete graduate degrees from Johns Hopkins in biotechnology and regulatory science.

Monique is a regulatory scientist, which puts her at the convergence of basic science, medical research, and law. At each stage of the drug development process, Monique works with her colleagues to make sure that the research plan for a potential medicine — the plan for making sure it shows safety and efficacy once it’s tested in clinical trials — is in line with what regulatory agencies like the FDA require. She’s a pro at identifying potential bumps in the road to getting medicines to patients, and for navigating those bumps.

A patient’s simple, two-word decree motivates Monique’s work: “I’m waiting.” Monique has continuously heard the same central theme from dedicated patient advocates— the need for expedited drug approval. “I’m elated that the FDA is now committed to considering such patient perspectives when assessing benefit/risk and making product approval decisions,” she says.   

Monique’s work took on a whole new level of significance when her mom and aunt were both diagnosed with breast cancer months apart. “I am grateful to have attended many ‘cancerversary’ celebrations for each of them thanks, in part, to timely access to safe and effective innovative therapies.” Her work allows for families just like hers to continue to have options in the face of disease with the help of the right treatment.  

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