The Graduate Certificate in Biopharmaceutical Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.
Duration of Program
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.
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): 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.
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
Domestic application complete (first half start: September 20, 2021)
September 7, 2021
Domestic application complete (second half start: November 1, 2021)
October 18, 2021
Recommended Admissions Deadline:
Domestic application complete (first half start: January 10, 2022)
December 20, 2021
Domestic application complete (second half start: February 22, 2022)
February 8, 2022
Recommended Admissions Deadline:
Domestic application complete (first half start: April 11, 2022)
March 28, 2022
Domestic application complete (second half start: May 23, 2022)
May 9, 2022
Recommended Admissions Deadline
Domestic application complete (first half start: July 11, 2022)
June 27, 2022
Domestic application complete (second half start: August 8, 2022)
July 25, 2022
Graduate Certificate in Biopharmaceutical Regulatory Affairs General Requirements
RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
RGA 6101 - Therapeutic Product Development: A Regulatory Overview
RGA 6207 - Global Impact of Electronic Common Technical Document (eCTD) Submissions
RGA 6380 - Advanced Regulatory Writing: New Drug Applications
Complete one of the following:
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
RGA 6235 - Emerging Product Categories in the Regulation of Drugs and Biologics
Please note: This curriculum is for marketing purposes only and is subject to change. Official curriculum can be found within the course catalog.
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.
Our faculty represents a wide cross-section of professional practices and fields ranging from finance to education to biomedical science to management to the U.S. military. They serve as mentors and advisors and collaborate alongside students to solve the most pressing global challenges facing established and emerging markets.
Head of Regulatory Services, Professor and Advisor in Regulatory Affairs, Reimbursement, Pricing and Health Economics
By enrolling in Northeastern, you gain access to a network of more than 275,000 alumni and 3,350+ employer partners, including Fortune 500 companies, government agencies, and global nongovernmental organizations. Our current students and faculty across strategically located regional locations further foster a lifelong, global community of learning and mentoring.
Below is a look at where our regulatory affairs alumni work, the positions they hold, and the skills they bring to their organization.