Master of Science in Regulatory Affairs – Boston
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.
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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.
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Customize your plan
We work with you to map your path to your goal.
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Learn from experience
From real-world case studies to employer-based projects, we prepare you to manage what comes next.
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Choose your focus
Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.
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Study anywhere, on your time
Part-time or full-time, we move at your speed, to get you where you’re going.
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 program is based in Boston, MA.
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.
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.
Get Set With a Custom Course Plan
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
General Requirements
| 2.00 | ||
| 5.00 | ||
| 5.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 |
Note: Students may select RGA 6203 or RGA 6204, but not both.
Capstone
| 4.00 |
The remaining quarter hours may be completed by selecting a combination of a concentration and additional electives or selecting any courses listed in the concentrations and elective lists.
Elective Courses
General Electives
| 3.00 | 4.00 | |
| 2.00 | ||
| 3.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 2.00 | ||
| 2.00 |
Regulatory Affairs of Food
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 3.00 |
International Regulatory Affairs
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 2.00 | ||
| 4.00 |
Concentrations
Biopharmaceutical Regulatory Affairs
| 2.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 |
Complete one of the following:
| 4.00 | ||
| 4.00 |
Clinical Research Regulatory Affairs
| 4.00 | ||
| 4.00 |
Choose one of the following:
| 4.00 | ||
| 4.00 |
Complete one of the following:
| 4.00 | ||
| 4.00 |
Medical Device Regulatory Affairs
| 2.00 | ||
| 4.00 | ||
| 4.00 |
Choose one from the following:
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 2.00 | ||
| 4.00 |
Nonclinical Biomedical Product Regulation
| 4.00 | ||
| 4.00 | ||
| 4.00 |
Complete one of the following:
| 4.00 | ||
| 4.00 |
Quality Assurance and Compliance
Complete one of the following:
| 2.00 | ||
| 2.00 | ||
| 3.00 |
Complete the following:
| 4.00 | ||
| 4.00 | ||
| 2.00 |
Choose from the following to reach 16 quarter hours:
| 4.00 | ||
| 4.00 | ||
| 3.00 |
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
average years of professional experience in regulatory affairs
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 an 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.
Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.
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
The PlusOne Accelerated Master’s Program provides motivated students with the opportunity to start earning their master’s degree while pursuing their undergraduate education. By completing the BS in Biotechnology, you can advance your learning by applying up to 16 earned semester hours (or up to 22.5 quarter hours) toward both 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 Science in Regulatory Affairs program.
View the registrar’s website for program-specific information
Stackable Certificates
You can stack the following Graduate Certificates into this degree: Biopharmaceutical Domestic Regulatory Affairs, Biopharmaceutical International Regulatory Affairs, Medical Devices Regulatory Affairs, Quality Assurance in Biomedical Product Regulation, Non-clinical Regulation of Biomedical Products
Cost and Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2022-2023 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time. For more detailed information, please visit Student Financial Services.
Application Deadlines
Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:
Domestic Application Guidelines
International Application Guidelines*
*International deadlines are only applicable if the program is F1 compliant.
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.
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Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
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What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
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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.