Biopharmaceutical Regulatory Affairs
Certificate
The Graduate Certificate in Biopharmaceutical Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.
Program overview
Bring products from lab to market
As biotechnology and pharmaceutical companies rapidly seek federal product approval, demand is growing for qualified regulatory affairs professionals. The Graduate Certificate in Biopharmaceutical Regulatory Affairs provides you 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.
Please note: Beginning fall 2026, this program will shift from a quarter-based academic calendar to a semester format. View the program conversion guide for curriculum details or visit our FAQ page for more information.
If you enter this program before fall 2026, your academic advisor will work with you to ensure a smooth transition. This change will not impact your academic progress, path to graduation, or tuition costs.
As biotechnology and pharmaceutical companies rapidly seek federal product approval, demand is growing for qualified regulatory affairs professionals. The Graduate Certificate in Biopharmaceutical Regulatory Affairs provides you 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.
Please note: Beginning fall 2026, this program will shift from a quarter-based academic calendar to a semester format. View the program conversion guide for curriculum details or visit our FAQ page for more information.
If you enter this program before fall 2026, your academic advisor will work with you to ensure a smooth transition. This change will not impact your academic progress, path to graduation, or tuition costs.
- 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.
F-1 students must be full-time students during their first term and can take a reduced course load in their final academic term, as long as there are no other degree requirements. Students are not eligible for OPT, as they have not completed one academic year.
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.
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
Deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of highly regulated products, including food, drugs, biologics, and medical devices.
Understand the critical U.S. regulations governing biopharmaceutical products and the FDA approval process.
Learn to efficiently guide biopharmaceutical products through the regulatory landscape while maintaining compliance and reducing costs.
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.
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
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$15,120Tuition 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.
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