Regulatory writers serve as a bridge between clinical teams, scientists, and regulators. They transform complex data into accurate, clear, and compliant documents according to highly specific guidelines.
UChicago’s online non-credit certificate program in Regulatory Writinggives you the training needed to write submissions to the FDA and other regulatory bodies. This program will provide you with highly technical, high-demand, professionally valuable writing skills in as little as four months, part-time.
Video Url
Build a Career That Positively Affects Others
Technical writing isn’t just about following style guides and checking references—it’s about bridging the gap between complex ideas and the people who need to understand them. A career in regulatory writing is ideal for those who want to be at the forefront of bringing new medical treatments and innovations to market.
As a regulatory writer, you will create essential documents that support drug approvals, clinical trials, and compliance with global regulatory standards, directly contributing to patient safety and access to new therapies.
Designed For
Designed for professionals with backgrounds in the healthcare industry or technical writing who are interested in embarking upon or shifting into a career in regulatory writing.
In-Demand Skills in a Globally Expanding Field
As US and global demand for regulatory professionals continues to grow, driven by increasing complexity in healthcare regulations, drug development, and medical device approval, this field offers strong career prospects. The specialized nature of the work supports long-term job stability, opportunities for advancement, and competitive compensation across pharmaceutical, biotech, and medical device industries.
Think Bigger About Career Possibilities
Gain training in the complete regulatory cycle, from editing biomedical packets to preparing protocol amendments and submissions.
This program is designed to be flexible, rigorous, and career-oriented, providing ongoing and impactful engagement with instructors and peers. It aligns closely with the needs of professionals looking to enter or advance in the life sciences and regulatory fields.
Courses are delivered in an asynchronous format, complemented by one live session per week. Each week includes self-paced lectures, readings, assignments, and discussion forums.
The program offers practical assignments based on real-world scenarios, instructor feedback, peer engagement, and opportunities for individual coaching.
Two courses
Introduction to Regulatory Writing: This course equips students with the tools to compile the components of a biomedical regulatory packet for submission to regulatory and oversight bodies such as the FDA, IRB, and IBC.
Regulatory Intelligence: This advanced course will cover FDA submissions, supportive documentation for major clinical trial milestones, responding to regulatory review, and writing about regulations. Learn the intricacies of FDA device, drug, and biologic submissions and gain familiarity with preparing and submitting required regulatory documents.
* Continuing Medical Education (CME) credits can be claimed at the course level.
Targeted Teaching from Industry Professionals
Our program instructors are leaders crafting current regulations and shaping the ethics and future of the healthcare communication industry. With years of experience in regulatory affairs and healthcare compliance, our instructors provide knowledge that you can start applying to your career today.
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.
Networking & Career Connections: Interactive engagement with peers and instructors, as well as career development resources, events, and webinars designed to foster connection and community.
Resources and Events: Webinars, career panels and more to foster industry connections.
Career Guidance: Resume positioning, job search strategy, and further learning opportunities.
Nancy Dudek, Certificate in Regulatory Writing
There are a lot of researchers who are great at experimental design and doing experiments, but when it comes to writing about it and writing in a way that’s accessible for other people, I think that can be a rarer skill.
Participants in the Regulatory Writing program will receive a digital course badge after the successful completion of each certificate course and a certificate of completion once all program requirements are met.
Sample of Non-Credit Digital Course Badge and Certificate.
Make Complex Medical Information Clear and Accessible
The online Regulatory Writing certificate program expands on the experiential professional development opportunities that we offer via a comprehensive portfolio of stackable healthcare certificate training options in Medical Writing and Editing and Healthcare Communications. This portfolio of competencies encompasses key specialty areas of the industry including publications, regulatory writing, marketing and public relations, health education, and writing for patients and the public.
Medical Writing Certificate
Master the fundamentals and best practices of medical writing and editing.
Vishwani Sahai, MD, certificate in Medical Writing and Editing
Add Regulatory Writing to Your Skill Set
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.
