Building on the foundation of our Medical Writing and Editing Training Certificate program, the Regulatory Writing microcertificate provides students with highly technical training in crafting precise, high-impact regulatory documents—an increasingly valuable skill set in the medical and scientific communications.
Regulatory writers serve as bridges between clinical teams, scientists, and regulators. They transform complex data into accurate, clear, and compliant documents according to highly specific guidelines. UChicago’s Regulatory Writing microcertificate gives you the training needed to write submissions to the FDA and other regulatory bodies. This microcertificate will provide you with highly technical, high-demand, professionally valuable writing skills in as little as four months.
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.
Formal Training, Modern Approach
This microcertificate 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 regulatory field.
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 microcertificate offers practical assignments based on real-world scenarios, instructor feedback, peer engagement, and opportunities for individual advising.
Regulatory Writing Microcertificate Curriculum
Students who have chosen to take REGW1110 Introduction to Regulatory Writing as their writing concentration course in the Medical Writing and Editing Training Certificate only need to complete REGW11200 to earn the microcertifcate.
Qualified and approved individuals interested in completing the Regulatory Writing Microcertificate separately from the Medical Writing and Editing Training Certificate may do so.
Online, self-paced with weekly synchronous sessions
Investment
$1,640
This course is designed to introduce regulatory writing as both a broad and specific skill set. Students will work to develop the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. For the purposes of this course, the regulatory packet includes the protocol and its amendments, the investigator's brochure, informed consent forms, and other submissions to regulatory and oversight bodies such as the IRB and IBC.
Students will learn how to:
Navigate and respond to the current regulatory environment of biomedicine from pharma and devices to innovative cellular therapies.
Identify and edit an array of regulatory documents and submissions.
Collaborate with a team on the roles of legal justification and rationale.
Begin to tailor their regulatory writing to meet specific audience requirements.
Online, self-paced with weekly synchronous sessions
Investment
$1,640
This advanced course will cover FDA submissions as well as regulatory writing and documents associated with the major clinical trial milestones, responding to regulatory review, and writing about regulations. Students will learn the intricacies of FDA device, drug, and biologic submissions; gain knowledge and familiarity with the preparation and submission of specific FDA documents and correspondence in accordance with requirements and best practices; further understand the regulatory writing components of clinical trials from start up to close out; and begin to think about regulatory documents from a reviewer’s perspective and practice drafting responses.
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.
Apply 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.
Targeted Teaching from Industry Professionals
Our program instructors are leaders in understanding current regulations and shaping the ethics and future of the healthcare communication industry. With years of experience in regulatory affairs and healthcare compliance, they 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.
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.
Get a Skills Boost With a Built-in Network
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 and more to foster industry connections and further learning opportunities.
Career Guidance: Resume positioning, career panels, job search strategy.
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.
