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 micorcertificate in Regulatory Writinggives you the training needed to write submissions to the FDA and other regulatory bodies. Gain highly technical, high-demand, professionally valuable writing skills in as little as four months.
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.
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.
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 micorcertificate offers practical assignments based on real-world scenarios, instructor feedback, peer engagement, and opportunities for individual advising.
Gain Important Skills in Just Four Months
Building on the foundation of our Medical Writing and Editing Training 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. 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.
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.
Students can complete the certificate in as little as four months.
Classes are offered remotely with live, interactive, synchronous sessions conducted through Zoom.
Attendance to synchronous sessions is mandatory.
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 certificate in Medical Writing 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 programs offer.
It is more than a certificate—it is an educational experience.
