About This Program
Regulatory writers play a key role in the drug approval process. They develop documents that are submitted to regulatory agencies to initiate clinical trials and gain marketing approval for drugs. These in-demand professionals use their data interpretation skills and technical communication expertise to translate clinical data into digestible content for their intended audience.
In this one-course specialization, we’ll focus primarily on the documents needed for regulatory approval of drugs by the U.S. Food and Drug Administration. You’ll study the format and content requirements of regulatory documents and write excerpts of documents for regulatory submission. You’ll learn how to read, interpret and summarize data from clinical trials in various therapeutic areas. Along the way, you’ll hone your writing skills for a variety of audiences, including regulatory agencies, medical professionals, patients and the public.
Designed For
Technical writers and medical or research professionals looking to break into the field of regulatory writing or broaden their knowledge of regulatory documents.
▸ Explore More: Check out other programs in communications, writing and editing.
Skills You’ll Gain
Drug development and approval lifecycle
Regulatory guidelines
Regulatory documents
Clinical data interpretation
Scientific writing
Technical writing
Plain language writing
Quality control review
Project management
Medical terminology
Get Real-World Experience
You’ll develop excerpts of the most common documents that regulatory writers work with to add to your professional portfolio.
Career Stats
13%
Projected growth in U.S. demand for technical writing skills (2025–27)
6%
Projected growth in U.S. demand for scientific writing skills (2025–27)
Career-Ready Credentials
When you complete this program, you'll earn a certificate and a digital achievement badge you can use to showcase your professional development.
Our Enrollment Coaches Are Here to Help
Connect with an enrollment coach to learn more about this offering. Or if you need help finding the right certificate, specialization or course for you, reach out to explore your options.
This program is intended for professional development and is not designed to meet educational requirements for professional licensure or certification.
