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Regulatory Writing

Curriculum

Overview

Be in Demand, in Just Three Months.

Building on the strengths of our Medical Writing and Editing program, Regulatory Writing courses will provide students with highly technical, high-demand, professionally valuable writing skills. You will learn to: 

  • 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

Regulatory Writing Program Structure

  • Two required courses
  • Class sizes range from ten to twenty students per course
  • Students can complete the certificate in as little as two quarters

Remote Course Format

  • Two-course program, each seven weeks in length
  • All remote courses start on a Monday with a full week of self-study activities in Canvas, our learning management system
  • Weekly, self-paced learning and materials are time-sensitive and must be completed within required timeframes
  • Weekly, self-paced learning in Canvas leads to one synchronous session per week
  • When registering for a course, "Online self-paced" refers to the course's beginning and end dates, "Online fixed dates" refer to synchronous sessions.
  • Synchronous sessions are conducted through Zoom
  • Attendance to synchronous sessions is mandatory

Courses

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Join a Fast Growing Segment in a Fast Growing Industry

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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