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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 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.
- Online format designed for working professionals
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.
Complete one of the following:
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 (500–1,000 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.
Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.
Cost and Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2023-2024 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.
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 Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.
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:
*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.
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
Learn more about Northeastern alumni on Linkedin.