Non-Credit Certificates Online

Regulatory Writing


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 on 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 Carter, MS

Regulatory Manager, University of Chicago Cancer Center

Leah Carter is a Jaharis Health Law Institute Fellow and a regulatory manager in the University of Chicago’s Cancer Center Clinical Trials Office. With a focus on FDA law, ethics, and the intersection between regulatory compliance and access to healthcare, Leah has more than twelve years’ experience...

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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 20 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., MSc.RA.

Senior Director of Data Disclosure and Transparency, BeiGene

Erik Lakes has over 15 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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