Master of Science in Regulatory Affairs – Boston
The Master of Science in Regulatory Affairs is a STEM degree that empowers you to manage global regulatory processes for companies who innovate and develop cutting-edge products in healthcare and food safety.
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Overview
The global convergence of regulatory science, technology-driven business decision making, formation of public policies, and evolving regulations are driving demand for knowledgeable regulatory affairs professionals.
Northeastern University’s Master of Science in Regulatory Affairs is a unique STEM-designated graduate degree designed to prepare you to effectively manage the processes involved in bringing highly regulated products to market.
From discovery to commercialization, this regulatory affairs master’s degree covers the steps that are required to bring a highly regulated product to market (including food, drugs, biologics, and medical devices) both in the U.S. and around the globe.
Through a rigorous and targeted curriculum, students learn to integrate knowledge and broad perspectives to effectively manage the appropriate industry-specific regulatory process throughout a product’s life cycle - including development, marketing approval, and utilization.
By choosing one of five concentration tracks, students have the chance to increase their professional marketability while gaining deeper experience in key areas of regulatory affairs.
Program objectives
- 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.
Unique Features
- The program has a Science, Technology, Engineering and Mathematics (STEM) designation. This means international students with a 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.
- Students can focus on one of five unique concentrations spanning the entire discipline
- Students will participate in Integrative Experiential Learning and/or cooperative education program as part of their course of study
- Access to a monthly lecture series, ALERT, in which regulatory professionals lead an exploration of evolving global regulatory frameworks and industry trends.
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.
Popular Jobs
| Job Title | Growth Rate | Median Annual Salary |
|---|---|---|
| Regulatory Affairs Manager | 3% | $128,620K |
| Compliance Officers | 3% | $128,620K |
| Quality Control Manager | 2% | $107,000K |
| Project Management Specialist | 6% | $95,370K |
| Logisticians | 18% | $77,520K |
| Industrial Production Manager | 2% | $107,560K |
of all regulatory professionals hold a master’s degree or higher
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
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
- 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.
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
Concentrations
Follow Our Leaders
"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
About 137,000 new regulatory affairs jobs were filled in 2018. 68% of regulatory professionals pursue graduate studies.
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Stephen Amato
Global Regulatory Affairs, Market Access and Life Sciences Executive & Education AdministratorFull bio
"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
Cost and Tuition
Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2024-2025 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. Select programs at select campuses offer additional scholarships of up to 25% off the listed price for domestic students studying on campus. For more detailed information, please visit Student Financial Services.
For students interested in pursuing financial assistance or educational loans, additional educational costs, known as Cost of Attendance (COA) components, can be included in the calculation of aid and loan eligibility. Components may include food, housing, books, course materials, supplies, equipment, transportation, personal expenses, and the cost of obtaining a first professional licensure. You can find comprehensive details on the Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.
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.
Did you know?
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.
Related Programs
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