Regulatory Affairs
The Master of Science in Regulatory Affairs program is designed to produce graduates who are highly qualified to manage global regulatory process for companies innovating and developing cutting-edge products in healthcare and food safety.
Part-Time
The ongoing global convergence of regulatory science, technology-driven regulatory decision making, formation of public policies, and ever-changing regulations are driving demand for regulatory affairs professionals who can help companies effectively bring 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 designed to deepen your understanding of the global compliance requirements for the development, marketing approval, and utilization of highly regulated products, including food, drugs, biologics, and medical devices.
Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the appropriate industry-specific regulatory process throughout a product’s life cycle. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a highly regulated product to market, both in the U.S. and around the globe.
Northeastern’s MS in Regulatory Affairs offers students the opportunity to meet their career goals and gain deeper experience in key areas of regulatory affairs—such as operational and strategic regulatory affairs, clinical regulatory affairs, new gene therapies, cybersecurity of medical devices, quality assurance in biopharmaceutical product formulation, validation of medical device commercialization, food safety, and regulatory compliance—by focusing their education in one of five unique concentrations that span the entire discipline. Concentration offerings include:
- Biopharmaceutical Regulatory Affairs
- Clinical Research Regulatory Affairs
- Medical Device Regulatory Affairs
- Nonclinical Biomedical Product Regulation
- Quality Assurance and Compliance
More Details
Unique Features
- Online program provides flexibility and interactive experience for working professionals.
- 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.
- The program has a Science, Technology, Engineering, and Mathematics (STEM) designation. This means international students 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.
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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)
Admissions Dates
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.
| Recommended Admissions Deadline: | |
|---|---|
| International out-of-country application complete (start date: September 14, 2020) | July 13, 2020 |
| International in-country application complete (start date: September 14, 2020) | August 10, 2020 |
| Domestic application complete (first half start: September 14, 2020) | September 4, 2020 |
| Domestic application complete (second half start: October 26, 2020) | October 16, 2020 |
| Recommended Admissions Deadline: | |
|---|---|
| International out-of-country application complete (start date: January 11, 2021) | November 2, 2020 |
| International in-country application complete (start date: January 11, 2021) | December 7, 2020 |
| Domestic application complete (first half start: January 11, 2021) | January 1, 2021 |
| Domestic application complete (second half start: February 22, 2021) | February 12, 2021 |
| Recommended Admissions Deadline: | |
|---|---|
| International out-of-country application complete (start date: April 12, 2021) | February 8, 2021 |
| International in-country application complete (start date: April 12, 2021) | March 8, 2021 |
| Domestic application complete (first half start: April 12, 2021) | April 2, 2021 |
| Domestic application complete (second half start: May 24, 2021) | May 14, 2021 |
| Recommended Admissions Deadline: | |
|---|---|
| International out-of-country application complete (start date: July 12, 2021) | May 10, 2021 |
| International in-country application complete (start date: July 12, 2021) | June 7, 2021 |
| Domestic application complete (start date: July 12, 2021) | July 2, 2021 |
General Requirements
Note: Students may select RGA 6203 or RGA 6204.
Capstone
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
Regulatory Perspective: Product Development, Business, and Strategy
International Regulatory Affairs
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.
Concentrations
Choose one from the following:
Complete the core courses below to meet the total number of program quarter hours:
Complete the core courses below to meet the total required number of program quarter hours:
Choose one of the following:
Complete the core courses below to meet the total required number of program quarter hours:
Complete the core courses below to meet the total required number of program quarter hours:
Complete the core courses below to meet the total number of program quarter hours:
Choose one:
Students in the Quality Assurance and Compliance concentration may enroll in RFA 6100, RGA 6000, or RGA 6001 to satisfy the core course requirement.
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
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.
By enrolling in Northeastern, you gain access to a network of more than 255,000 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.
-
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.