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College of Professional Studies

Clinical Research Regulatory Affairs

Certificate

The Graduate Certificate in Clinical Research Regulatory Affairs helps you develop a comprehensive understanding of rapidly evolving clinical research, global biomedical product regulatory standards, and processes.

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Program Format
Online
Time Commitment
Part time, Full time
Duration
6 - 12 Months
Entry Term(s)
Fall, Spring
Meets F1 visa requirements
No

Program overview

Keep clinical research compliant

Clinical research regulations change quickly and constantly. In the Graduate Certificate in Clinical Research Regulatory Affairs program, you’ll learn to keep up with new regulations and maintain patient safety as you help organizations develop groundbreaking technologies.

As a graduate of this program, you’ll be able to understand global standards and requirements, research processes, key compliance techniques, and the differences in clinical and non-clinical regulations. With alumni working at major companies worldwide, you’ll also be connected to a valuable network of peers who can help you advance your career.

  • Gain a global perspective as you study alongside students from more than 20 countries.
  • Connect with alumni working at the world’s largest pharmaceutical, biologic, medical device, nutraceutical, and cosmeceutical product and service manufacturers including Genzyme, Boston Scientific, Edwards Lifesciences, PRA Health Sciences, Alexion Pharmaceuticals, Pfizer, Novartis, Merck, Nestlé, PepsiCo, and Coca-Cola.
  • Stack credits from this certificate program into Northeastern’s Master of Science in Regulatory Affairs.

Admissions

Apply to the program

A graduate degree or certificate from Northeastern can accelerate your career through rigorous academic coursework and real-world professional experience in your area of interest. Apply to take your career to the next level.

Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:

Domestic Application Guidelines

International Application Guidelines*

*International deadlines are only applicable if the program is F1 compliant.


  • Online application

  • Professional resumé

  • Unofficial undergraduate transcripts; official transcripts required at the time of admission

    • The Foreign Credential Evaluation (FCE) is a required assessment of all transcripts and documents from non-U.S. accredited post-secondary education institutions. (Review the FCE requirements by country.)

  • English language proficiency proof. Students for whom English is not their primary language must submit one of the following:

    • Official associate or bachelor's degree transcript from an accredited college or university in the U.S., stating degree conferral and date

    • TOEFL, IELTS, PTE, Duolingo, or NU Global Exam scores

  • Other materials may be required

Program objectives

Prepare for success

Build your foundation in regulatory affairs through classes and projects based on real-world challenges.

Master global regulatory standards

Develop a comprehensive understanding of evolving international biomedical product regulatory standards and compliance requirements.

Navigate clinical research processes

Gain expertise in the complex regulatory processes specific to clinical research and patient-facing biomedical product development.

Ensure regulatory compliance

Build professional competencies required to conduct regulatory processes for new biomedical products in accordance with global standards and regulatory agency requirements.

Differentiate between regulation types

Understand the separation between clinical regulatory processes and those applicable to indirect, non-patient-facing development.

Connect with us

Want more information?

We’re here to answer your questions about this program, the application process, and more. Complete the form below to receive additional program details and speak with a member of our enrollment team. 

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Degree building

Stack your certificate

Earning a graduate certificate is a fast and affordable way to acquire specialized skills while building toward your master’s degree. Upon completion of this certificate program, you may be able to apply your credits to an eligible master’s program, saving time and money on your degree.

Some of the eligible master’s programs for this certificate include:

Contact an enrollment counselor to learn more about eligibility requirements.

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Cost of attendance

Tuition and financial aid

  • $14,592
    Tuition in USD

Estimated Total Tuition

This is an estimate based on the tuition rates for Academic Year 2025-2026 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time. Select programs at select campuses offer additional scholarships of up to 25% off the listed price for domestic students studying on campus. For more detailed information, please visit Student Financial Services.

For students interested in pursuing financial assistance or educational loans, additional educational costs, known as Cost of Attendance (COA) components, can be included in the calculation of aid and loan eligibility. Components may include food, housing, books, course materials, supplies, equipment, transportation, personal expenses, and the cost of obtaining a first professional licensure. You can find comprehensive details on the Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.

There are many ways to pay for your education, including scholarships, financial aid, and more. Connect with a financial counselor to learn about your options and make your dream a reality.

Visit tuition & financial aid
Online Programs

Your education, your way

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Northeastern's online classes give you the same top-tier education you'd get in person, on a schedule that works for your lifestyle and career needs. They offer a range of videos, interactives, breakout sessions, and experience-focused learning opportunities to immerse you in the material and build community. You'll graduate with the same degree as your in-person peers.

#8

Northeastern's national ranking for Most Innovative Schools

(U.S. News & World Report, 2024)

53.5%

Percent of graduate students in the U.S. enrolled in online courses

(NCES, 2022)

97%

Percent of students in the U.S. who recommend online education

(BestColleges, 2024)