Non-Credit Certificates Online

Regulatory Writing

Instructors

Learn from the Best

The Regulatory Writing certificate instructors at the University of Chicago are active practitioners in the healthcare industry, having decades of experience in medical writing and editing. Their extensive field expertise in regulatory affairs adds an essential practical component to our courses, providing real-world instruction in executing successful regulatory submissions. Additionally, our instructors provide a dynamic learning environment designed to teach you exactly what you need for your career today. 

Connect with Expert Instructors

Leah Carter, Medical Writing and Editing instructor

Leah D.B. Carter, JD, MS

Assistant State's Attorney

Leah Carter is an Assistant State's Attorney. She began her regulatory career in the early 2000s and has focused on FDA law, ethics, and the intersection between regulatory compliance and access to healthcare for the past ten years. Her published work discusses interventional cures, stigma...

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Regulatory Writing instructor Pamela Gonzalez headshot.

Pamela Gonzalez, BA

Research Operations, Office of Clinical Research, UChicago

Pam is a healthcare leader with over twenty years of clinical research experience. Her work focuses on regulatory compliance, ethics, and quality management systems. Pam has firsthand perspective as grant writer, auditor, ISO inspector, principal investigator, regulatory manager, quality management...

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Erik Lakes Headshot

Erik Lakes, MSc, MScRA

Senior Director of Data Disclosure and Transparency, BeiGene

Erik Lakes has over fifteen years of experience working in the biopharmaceutical industry. He is the Senior Director and Head of Data Disclosure and Transparency for BeiGene, Ltd., where he is responsible for trial disclosure and data transparency compliance worldwide. Prior to joining BeiGene, Erik...

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A medical professional studying in an open room with a laptop.

Knowledge You Can Take from the Classroom to Your Career

With an instructional team of medical and regulatory writing experts, our certificate is the most effective way to get direct access to their leading-edge insights.

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