The Graduate Certificate in Biopharmaceutical Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.
Duration of Program
Fall, Spring, Summer, Winter
Meets F1 Visa Requirements
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.
A graduate degree or certificate from Northeastern—a top-50 university—can accelerate your career through rigorous academic coursework and hands-on professional experience in the area of your interest. Apply now—and take your career to the next level.
How to Apply Learn more about the application process and requirements.
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.
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 deadlines are only applicable if the program is F1 compliant.
Industry-aligned courses for in-demand careers.
For 100+ years, we’ve designed our programs with one thing in mind—your success. Explore the current program requirements and course descriptions, all designed to meet today’s industry needs and must-have skills.
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.
Northeastern University faculty represents a broad cross-section of professional practices and fields, including finance, education, biomedical science, management, and the U.S. military. They serve as mentors and advisors and collaborate alongside you to solve the most pressing global challenges facing established and emerging markets.
By enrolling in Northeastern, you’ll gain access to students at 14 campus locations, 300,000+ alumni, and 2,900+ employer partners worldwide. Our global university system provides students unique opportunities to think locally and act globally while serving as a platform for scaling ideas, talent, and solutions.
Below is a look at where our regulatory affairs alumni work, the positions they hold, and the skills they bring to their organization.