Certificate in Regulatory Writing

In regulatory affairs, your writing directly impacts approvals, timelines, and outcomes. The Certificate in Regulatory Writing helps you develop the clarity, precision, and strategic communication skills needed to move products forward and reduce risk.

Created by experienced regulatory professionals, this program helps you write with purpose so your documents are understood, your teams stay aligned, and your submissions stand out.

Ideal for early-career regulatory and quality professionals, it delivers practical, job-ready skills you can apply immediately.

Program Details

This certificate is achieved by completing two (2) core and three (3) elective courses.  After successfully completing all five courses, you will receive a certificate recognizing your achievement.

You have twelve (12) months to complete all five (5) courses.

Core Courses 

The following four courses are required as part of the program requirements:

• Regulatory Documentation: An Introduction
• Regulatory Writing: Plain Language

Elective Courses

You also choose three of the following courses:

• Regulatory Writing: Building a Successful Culture for Collaborative Writing
• Pharmaceutical Labeling: Introduction to an Essential Function
• Intermediate Medical Writing: Medical Devices
• Intermediate Medical Writing: Pharmaceuticals and Biologics
• Intermediate Medical Writing: Investigational Applications