RGA

Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs — Online

The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.

Take a quick look

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.

01

Customize your plan

We work with you to map your path to your goal.

02

Learn from experience

From real-world case studies to employer-based projects, we prepare you to manage what comes next.

03

Choose your focus

Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.

04

Study anywhere, on your time

Part-time or full-time, we move at your speed, to get you where you’re going.

Enrollment

Part-Time

Entry Terms

Fall, Spring, Summer, Winter

Completion Time

6-12 months

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 Domestic 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.

More Details

Unique Features

  • Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
  • Online format designed for working professionals

Experiential / Co-op opportunities

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.

Learn About Getting Real World Experience

Get Set with a Custom Course Plan

General Requirements

2.00
4.00

Complete the appropriate number of electives to meet the minimum quarter-hour requirement: 

4.00
2.00
5.00
4.00
4.00
4.00
4.00
4.00
4.00
4.00
4.00

 

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 (500–1000 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

International Requirements

Are You an International Student? Find out what additional documents are required to apply.

Global Engagement Learn how our teaching and research benefit from a worldwide network of students, faculty, and industry partners.

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

Application Deadlines

Our admissions process operates on a rolling basis; however, we do recommend following the application guidelines below to ensure you can begin during your desired start term.

Winter 2021 Deadline
November 2, 2020International out-of-country application complete (start date: January 19, 2021)
December 7, 2020International in-country application complete (start date: January 19, 2021)
January 1, 2021Domestic application complete (first half start: January 19, 2021)
February 12, 2021Domestic application complete (second half start: February 22, 2021)
Spring 2021 Deadline
February 8, 2021International out-of-country application complete (start date: April 12, 2021)
March 8, 2021International in-country application complete (start date: April 12, 2021)
April 2, 2021Domestic application complete (first half start: April 12, 2021)
May 14, 2021Domestic application complete (second half start: May 24, 2021)
Summer 2021 Deadline
May 10, 2021International out-of-country application complete (start date: July 12, 2021)
June 7, 2021International in-country application complete (start date: July 12, 2021)
July 2, 2021Domestic application complete (start date: July 12, 2021)
Fall 2021 Deadline
July 19, 2021International out-of-country application complete (start date: September 20, 2021)
August 23, 2021International in-country application complete (start date: September 20, 2021)
September 7, 2021Domestic application complete (first half start: September 20, 2021)
October 18, 2021Domestic application complete (second half start: November 1, 2021)

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

    • Shire
    • Pfizer
    • Medtronic
    • Biogen
    • Teva Pharmaceuticals
  • What They Do

    • Legal
    • Research
    • Quality Assurance
    • Operations
    • Healthcare Services
  • What They're Skilled At

    • Regulatory Affairs
    • Pharmaceutical Industry
    • U.S. Food and Drug Administration
    • Clinical Trials
    • Standard Operating Procedure (SOP)

 

Learn more about Northeastern Alumni on Linkedin.

Career Opportunities and Services

Overview

Did You Know?

Nearly all RASI professionals (99%) have university degrees, and 69% have pursued postgraduate studies (RAPS, 2014).

 

Stackable Certificate

Credits earned completing this certificate can be applied toward the MS in Regulatory Affairs.

 

Did You Know?

By enrolling in Northeastern, you gain access to our global network of more than 255,000 alumni and 3,350+ employer partners. 

From Our Faculty

"Northeastern is a world-class university with a tremendous trajectory. It's a wonderful institution where faculty can make a significant impact." — Assistant Professor Stratis Ioannidis

From Our Alumni

"Northeastern's programs are led by skilled and experienced industry leaders who are committed to the engagement and growth of their students." — Stephen O'Halloran, '14