Graduate Certificate in Biopharmaceutical Regulatory Affairs-Boston
The Graduate Certificate in Biopharmaceutical Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.
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We’re committed to creating an education as unique as your career path. So, whether your goal is a new career or moving up in your field, our innovative programs will get you going your way.
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Customize your plan
We work with you to map your path to your goal.
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Learn from experience
From real-world case studies to employer-based projects, we prepare you to manage what comes next.
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Choose your focus
Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.
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Study anywhere, on your time
Part-time or full-time, we move at your speed, to get you where you’re going.
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 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.
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 (2 quarters having been completed rather than the 3 quarters that is the academic year).
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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.
Get Set With a Custom Course Plan
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
General Requirements
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Complete one of the following:
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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 (500–1,000 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)
- 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
International Requirements
Are You an International Student? Find out what additional documents are required to apply.
Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.
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 2024-2025 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.
Application Deadlines
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.
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
Learn more about Northeastern alumni on Linkedin.