Building on the foundation of our Medical Writing and Editing program, Regulatory Writing certificate courses provide students with highly technical training in crafting precise, high-impact regulatory documents—an increasingly valuable skill set in the medical and scientific communications. You will learn to:
Technical Writing That Speaks Volumes
Learning Outcomes:
Identify, edit, and contribute components of a biomedical regulatory packet.
Navigate the FDA submission and auditing process.
Prepare investigational new drug applications.
Create submissions for different categories of biomedical research including vaccines, devices, and other categories.
Gain practical, immediately applicable knowledge of regulatory writing formats.
Use the language, tone, and structure expected by regulatory bodies.
Utilize industry-relevant tools.
Use document planning, authoring, review, and version control processes.
Demonstrate strategic and ethical thinking in regulatory contexts.
Analyze real-world regulatory decisions, guidance documents, and submission strategies.
Work through hypothetical regulatory scenarios to build problem-solving skills.
Regulatory Writing Certificate Program Structure
Two required courses.
Class size averages ten to twenty students.
Core Courses
Introduction to Regulatory Writing
| REGW11100 | Online | 7 weeks
This course, designed to introduce regulatory writing as both a broad and specific skill set, teaches the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. Learn to navigate and respond to the current regulatory environment of biomedicine, identify and edit an array of regulatory documents and submissions, collaborate with a team on the roles of legal justification and rationale, and begin to tailor your regulatory writing to meet specific audience requirements.
This advanced course will cover FDA submissions, regulatory writing, supportive documentation for major clinical trial milestones, how to respond to regulatory review, and write about regulations. Students will learn the intricacies of FDA device, drug, and biologic submissions, and gain familiarity with the preparation and submission of required regulatory documents.
The program consists of two required courses with a flexible sequential course progression.
Students can complete the certificate in as little as four months.
The class size is limited to a maximum of twenty students.
Classes are offered remotely with live, interactive, synchronous sessions conducted through Zoom.
Attendance to synchronous sessions is mandatory.
Students will receive a digital credential at the successful completion of each course.
Upon successful completion of both courses, participants will receive a certificate of completion from the University of Chicago.
Leah Carter, Regulatory Writing instructor
The assignments aren’t just exercises. They’re structured for thinking critically about how regulations work in practice—how they evolve, how they’re communicated, and how they can be challenged or clarified.
Invest in a online Regulatory Writing certificate from UChicago and train with experts at the top of their field; engage in a program offering technical expertise along with soft skills; enter a top-tier community where you can grow your network; and receive the advising, events, networking, and opportunities our unique certificate program offer.
It is more than a certificate—it is an educational experience.
