Non-Credit Certificates Online

Regulatory Writing

Curriculum

Regulatory Writing Program Overview

Gain Important Skills in Just Four Months

Building on the foundation of our Medical Writing and Editing program, Regulatory Writing certificate courses provide 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.

Regulatory Writing Certificate Program Structure

  • Two required courses.
  • Students have up to three years to complete the full certificate.

Core Courses

Regulatory Writing online course format

  • The program consists of two required sequential courses.
  • Students can complete the certificate in as little as four months.
  • The class size is limited to a maximum of twenty students.
  • Classes are offered remotely with live, interactive, synchronous sessions conducted through Zoom.
  • Attendance to synchronous sessions is mandatory.

Earn a Credential in Regulatory Writing

Participants in the Regulatory Writing program will receive a digital course badge after the successful completion of each certificate course and a certificate of completion once all program requirements are met.

Sample of Non-Credit Digital Course Badge and Certificate.
Sample of Non-Credit Digital Course Badge and Certificate.
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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