RGA

Master of Science in Regulatory Affairs – Online

The Master of Science in Regulatory Affairs program will prepare you to manage global processes for organizations involved in developing and seeking marketing approval for regulated, cutting-edge products in healthcare and food safety.

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

Full-Time, Part-Time

Entry Terms

Fall, Spring, Summer, Winter

Completion Time

12-18 months

Overview

The global convergence of regulatory science, technology-driven business decision making, formation of public policies, and evolving regulations are driving demand for regulatory affairs professionals who can facilitate the processes involved in bringing highly regulated products to market. To prepare you to effectively manage regulatory activities, Northeastern University’s College of Professional Studies offers the Master of Science in Regulatory Affairs. This unique graduate degree is STEM-designated, and is designed to deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of technically complex and highly regulated products, including food, drugs, biologics, and medical devices.

This is an online program.


More Details

Unique Features

  • Students can focus on one of five unique concentrations spanning the entire discipline of global regulatory affairs in healthcare.
  • Students will participate in integrative experiential learning and/or the cooperative education program as part of their course of study.
  • Students will have the opportunity to forge connections with our global network of alumni from some of the world's most renowned companies, including Genzyme, Boston Scientific, Edwards Lifesciences, PRA Health Sciences, Alexion Pharmaceuticals, Pfizer, Novartis, Merck, Nestle, Pepsico, and Coca-Cola.
  • As a Northeastern University student and alumnus, you'll have access to a monthly lecture series, ALERT, in which regulatory professionals lead an exploration of evolving global regulatory frameworks and industry trends.
  • This program has a science, technology, engineering, and mathematics (STEM) designation. This means international students with an F-1 visa can apply for a 24-month OPT STEM Extension to their 12-month Optional Practical Training (OPT) period, which allows them to work in the U.S. for up to 36 months after graduation. Non-US students may take a certain number of online courses as approved by their advisor as long as they are enrolled in the required amount of on-ground coursework at our Boston or Silicon Valley campuses per term.In these approved instances, the degree is STEM eligible.

Program Objectives

Successful completion of the MS-RA Program will enable students to:

  • Gain the technical knowledge and skills required to enable stakeholders to navigate an increasingly complex global regulatory environment.
  • Acquire the professional foundations necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, clinical research, and food safety.
  • Manage the product life cycles of biopharmaceutical and medical devices from conception through launch to obsolescence.
  • Refine your understanding of the laws and standards that govern the development, manufacturing, and commercial distribution of drugs, biologics, medical devices, and food safety.
  • Analyze how emerging developments and trends are reshaping global biomedical product commercialization regulations.

Concentrations

  • Biopharmaceutical Regulatory Affairs—Learn how to apply statuses to the submission of marketing approval applications for both pharmaceutical and biological products to global regulatory agencies.
  • Clinical Research Regulatory Affairs—Provide practical knowledge of regulatory requirements and methodologies for clinical human and animal research to support biomedical product development.
  • Medical Device Regulatory Affairs—Learn how to apply statutes of the submission of marketing approval applications for medical device products to global regulatory agencies.
  • Nonclinical Biomedical Product Regulation—Study the regulations applicable to biomedical product commercialization from pre-clinical development, quality, and manufacturing perspectives.
  • Quality Assurance and Compliance—Study the application of standards and regulations to the development and commercialization of either healthcare or food products.

Check out your career prospects

Beginning your journey with us is a big decision. But it's a smart one. Your field is growing exponentially and evolving rapidly. That's why we're constantly innovating curriculum to anticipate your industry's needs. So no matter where regulatory affairs goes, you can lead the way.

42%

of all regulatory professionals hold a master’s degree or higher

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
5.00
5.00
4.00
4.00
4.00

Note:  Students may select RGA 6203 or RGA 6204.

Capstone

4.00
 

Required Electives

Complete electives to meet the total required number of program quarter hours. One course must be chosen from each category below, and additional electives may come from those lists or the topics list.

Regulatory Operations

4.00
4.00
4.00
4.00
4.00
3.00
3.00

Regulatory Perspective: Product Development, Business, and Strategy

4.00
3.004.00
2.00
3.00
1.00
4.00
4.00
4.00
4.00
4.00
4.00
4.00
2.00
2.00

International Regulatory Affairs

4.00
4.00
4.00
4.00
4.00
4.00
4.00
2.00
2.00
4.00
4.00
4.00

Please Note: Prior to enrolling in COP 6940 Personal and Career Development (COP 6940), students must:

  • complete 20 credit hours in the current program of study
  • maintain a cumulative GPA of 3.0 or higher
  • F1 Students only - need to complete 3 consecutive full-time terms

Regulatory Affairs Topics

Additional elective options to meet the total required number of program quarter hours. 

4.00
4.00
2.00
2.00
2.00
 

Concentrations

Biopharmaceutical Regulatory Affairs

Complete the core courses below to meet the total number of program quarter hours:

2.00
4.00
4.00

Clinical Research Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours: 

4.00
4.00

Choose one of the following:

4.00
4.00

Medical Device Regulatory Affairs

Complete the core courses below to meet the total required number of program quarter hours:

2.00
4.00

Nonclinical Biomedical Product Regulation

Complete the core courses below to meet the total required number of program quarter hours: 

4.00
4.00

Quality Assurance and Compliance

Complete the core courses below to meet the total number of program quarter hours:

Choose one: 

2.00
2.00

4.00
3.00

Students in the Quality Assurance and Compliance concentration may enroll in RFA 6100, RGA 6000, or RGA 6001 to satisfy the core course requirement.

Follow our leaders

Our faculty represents a wide cross-section of professional practices and fields. They serve as mentors and advisors and collaborate alongside students to solve the most pressing global challenges facing established and emerging markets.

A graduate degree helps students gain the expertise [these] companies are looking for through intensive curricula, specialized concentration coursework, and experiential learning opportunities.” - Stephen Amato, PhD, Faculty Director

10-15 years

average years of professional experience in regulatory affairs

Stephen Amato

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Steve Kates

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Angela Knox

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Maria Mancini

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Jennifer Scalise

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Thomas Koperniak

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The master’s degree in regulatory affairs that I received from Northeastern propelled my career from being an individual contributor to directing a large global network of regulatory professionals. The academic curriculum, the credentialing, and the vast network which I attained, allowed me to build the well-rounded, balanced and successful career I have today.

Kathy Reddig Master of Science in Regulatory Affairs

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 from the program. Please be aware that the university's academic policy on plagiarism applies to applicant's statement of purpose.
  • Professional resumé: Current resumé that displays job responsibilities, relevant experience, and education history
  • Two letters of recommendation from individuals with either academic or professional knowledge of your capabilities, such as a faculty member, current employer, mentor, or colleague
  • Official undergraduate degree documentation reflecting a degree in pharmacy, biology, chemistry, physics, biochemistry, nursing, physical therapy, health law, or health policy
    • Two or three years of work experience in the field can be substituted if an applicant holds a degree in area other than pharmacy or life sciences.
  • Proof of English language proficiency: Only for students for whom English is not their primary language: English language proficiency guidelines
  • Unofficial undergraduate transcripts (Official transcripts required at the time of admission)

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.

PlusOne

Your Head Start on a Master’s Degree

By completing the BS in Biotechnology, you can advance your learning by applying up to 16 credits earned toward your bachelor's and master’s degree, allowing you to receive your graduate degree one year sooner than you would with a traditional Master of Professional Studies in Analytics. Learn more about PlusOnes.

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

Thinking about pursuing a graduate degree?

Explore seven reasons to attend graduate school.

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Did You Know?

About 137,000 new regulatory affairs jobs were filled in 2018.

Did You Know?

68% of regulatory professionals pursue graduate studies.

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

"Experienced regulatory professionals are in demand. A graduate degree in regulatory affairs will help advance your career." — Professor Stephen Amato

Did You Know?

Advanced degree holders earn a salary 35% higher than those with a bachelor's degree.