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Overview
As biotechnology and pharmaceutical companies rapidly seek federal approval for products, demand is growing for qualified regulatory affairs professionals. The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of biopharmaceutical product regulation and the industry's evolving compliance requirements in the U.S.
Scientists developing new products and legal experts guiding them through the FDA approval process will benefit from regulatory affairs training. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement. Students will also develop a vocabulary of over 750 acronyms and technical/regulatory words to which FDA has applied its own distinctive meaning. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs.
More Details
Unique Features
- Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs
- Boston is a hub for healthcare, biotechnology, and life science sectors
Experiential / Co-op opportunities
Northeastern's signature experience-powered learning model has been at the heart of the university for more than a century. It combines world-class academics with professional practice, allowing you to acquire relevant, real-world skills you can immediately put into action in your current workplace.

This makes a Northeastern education a dynamic, transformative experience, giving you countless opportunities to grow as a professional and person.
Get Set with a Custom Course Plan
General Requirements
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Complete the appropriate number of electives to meet the minimum quarter-hour requirement:
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Now Let's Talk Admissions
You know where you are headed and you've seen how our program will lead you there. So let's get going. Here's what you need to know before you enroll.
Application Requirements
- Online application
- Statement of purpose (500–1000 words): identifies your educational goals and expectations from the program; please be aware that Northeastern University's academic policy on plagiarism applies to your statement of purpose
- Professional resumé
- Unofficial undergraduate transcripts (official transcripts required at the time of admission)
- 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
International Requirements
Are You an International Student? Find out what additional documents are required to apply.
Global Engagement Learn how our teaching and research benefit from a worldwide network of students, faculty, and industry partners.
Financing Requirements
Finance Your Education We offer a variety of resources, including scholarships and assistantships.
How to Apply Learn more about the application process and requirements.
Cost and Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2020-2021 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. For more detailed information, please visit Student Financial Services.
Application Deadlines
Our admissions process operates on a rolling basis; however, we do recommend following the application guidelines below to ensure you can begin during your desired start term.
Spring 2021
Recommended Admissions Deadline: | |
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International out-of-country application complete (start date: April 12, 2021) | February 8, 2021 |
International in-country application complete (start date: April 12, 2021) | March 8, 2021 |
Domestic application complete (first half start: April 12, 2021) | April 2, 2021 |
Domestic application complete (second half start: May 24, 2021) | May 14, 2021 |
Summer 2021
Recommended Admissions Deadline: | |
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International out-of-country application complete (start date: July 12, 2021) | May 10, 2021 |
International in-country application complete (start date: July 12, 2021) | June 14, 2021 |
Domestic application complete (first half start: July 12, 2021) | June 28, 2021 |
Domestic application complete (second half start: August 9, 2021) | July 26, 2021 |
Fall 2021
Recommended Admissions Deadline: | |
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International out-of-country application complete (start date: September 20, 2021) | July 19, 2021 |
International in-country application complete (start date: September 20, 2021) | August 23, 2021 |
Domestic application complete (first half start: September 20, 2021) | September 7, 2021 |
Domestic application complete (second half start: November 1, 2021) | October 18, 2021 |
Winter 2022
Recommended Admissions Deadline | |
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International out-of-country application complete (start date: January 10, 2022) | November 8, 2021 |
International in-country application complete (start date: January 10, 2022) | December 13, 2021 |
Domestic application complete (first half start: January 10, 2022) | December 20, 2021 |
Domestic application complete (second half start: February 22, 2022) | February 8, 2022 |
Spring 2022
Recommended Admissions Deadline | |
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International out-of-country application complete (start date: April 11, 2022) | February 7, 2022 |
International in-country application complete (start date: April 11, 2022) | March 14, 2022 |
Domestic application complete (first half start: April 11, 2022) | March 28, 2022 |
Domestic application complete (second half start: May 23, 2022) | May 9, 2022 |
Summer 2022
Recommended Admissions Deadline | |
---|---|
International out-of-country application complete (start date: July 11, 2022) | May 9, 2022 |
International in-country application complete (start date: July 11, 2022) | June 13, 2022 |
Domestic application complete (first half start: July 11, 2022) | June 27, 2022 |
Domestic application complete (second half start: August 8, 2022) | July 25, 2022 |
Student Body Profile
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.
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Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
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What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
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What They're Skilled At
- Regulatory Affairs
- Pharmaceutical Industry
- U.S. Food and Drug Administration
- Clinical Trials
- Standard Operating Procedure (SOP)
Learn more about Northeastern Alumni on Linkedin.