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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 the FDA has applied its own distinctive meaning.
- Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
- Online format designed for working professionals
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
Complete the appropriate number of electives to meet the minimum quarter-hour requirement:
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.
- Online application
- Statement of purpose (500–1000 words): identify your educational goals and expectations of 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
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.
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.
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.
|November 2, 2020||International out-of-country application complete (start date: January 19, 2021)|
|December 7, 2020||International in-country application complete (start date: January 19, 2021)|
|January 1, 2021||Domestic application complete (first half start: January 19, 2021)|
|February 12, 2021||Domestic application complete (second half start: February 22, 2021)|
|February 8, 2021||International out-of-country application complete (start date: April 12, 2021)|
|March 8, 2021||International in-country application complete (start date: April 12, 2021)|
|April 2, 2021||Domestic application complete (first half start: April 12, 2021)|
|May 14, 2021||Domestic application complete (second half start: May 24, 2021)|
|May 10, 2021||International out-of-country application complete (start date: July 12, 2021)|
|June 7, 2021||International in-country application complete (start date: July 12, 2021)|
|July 2, 2021||Domestic application complete (start date: July 12, 2021)|
|July 19, 2021||International out-of-country application complete (start date: September 20, 2021)|
|August 23, 2021||International in-country application complete (start date: September 20, 2021)|
|September 7, 2021||Domestic application complete (first half start: September 20, 2021)|
|October 18, 2021||Domestic application complete (second half start: November 1, 2021)|
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.
Where They Work
- Teva Pharmaceuticals
What They Do
- Quality Assurance
- Healthcare Services
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.
Career Opportunities and Services
Did You Know?
Nearly all RASI professionals (99%) have university degrees, and 69% have pursued postgraduate studies (RAPS, 2014).
Credits earned completing this certificate can be applied toward the MS in Regulatory Affairs.
Did You Know?
By enrolling in Northeastern, you gain access to our global network of more than 255,000 alumni and 3,350+ employer partners.
From Our Faculty
"Northeastern is a world-class university with a tremendous trajectory. It's a wonderful institution where faculty can make a significant impact." — Assistant Professor Stratis Ioannidis
From Our Alumni
"Northeastern's programs are led by skilled and experienced industry leaders who are committed to the engagement and growth of their students." — Stephen O'Halloran, '14