Non-Credit Certificates Online

Regulatory Writing

Curriculum

Regulatory Writing Program Overview

Gain Important Skills in Just Four Months

Building on the strengths of our Medical Writing and Editing program, Regulatory Writing certificate courses will provide students with highly technical, high-demand, professionally valuable writing skills. 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.
  • Learn the language, tone, and structure expected by regulatory bodies.
  • Utilize industry-relevant tools.
  • Learn document planning, authoring,review, and version control processes.
  • Enhance 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.

Regulatory Writing Certificate Program Structure

  • Two required courses.
  • Class size averages ten to twenty students.
  • Students can complete the certificate in as little as two quarters.

Core Courses

Regulatory Writing online course format

  • The program consists of two core requirements with a flexible sequential course progression.
  • Students can complete the certificate in as little as four to thirty-six months.
  • Class sizes range from ten to twenty students per course.
  • Classes are offered remotely with live, interactive, synchronous sessions conducted through zoom.
  • Attendance to synchronous sessions is mandatory.
  • After successful completion of core requirements, participants will receive a credential certified by the University of Chicago.
A medical professional reviews documents in his office.

Formal Training, Modern Approach

Learn how to apply and manage your regulatory writing skills in high-paced settings that will reshape your career and impact an entire industry.

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