Non-Credit Certificates | Online

Regulatory Writing

Curriculum

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Program overview
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Program structure
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Online course format
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Core courses

Program 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

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

Online 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

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Core courses

Introduction to Regulatory Writing

REGW11100 | Online | 7 weeks

This course, designed to introduce regulatory writing as both a broad and specific skill set, teaches the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. Learn to navigate and respond to the current regulatory environment of biomedicine, identify and edit an array of regulatory documents and submissions, collaborate with a team on the roles of legal justification and rationale, and begin to tailor your regulatory writing to meet specific audience requirements.

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Regulatory Intelligence

REGW11200 | Online | 7 weeks

This advanced course will cover FDA submissions, regulatory writing, supportive documentation for major clinical trial milestones, how to respond to regulatory review, and write about regulations. Students will learn the intricacies of FDA device, drug, and biologic submissions, and gain familiarity with the preparation and submission of required regulatory documents.

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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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