Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
|Campus Locations||Boston, Online, Charlotte, Seattle|
|Also available 100% Online||Yes|
|Credits Required for Graduation||45|
|Entry Terms||Fall Quarter, Winter Quarter, Spring Quarter, Summer Quarter|
|Meets International Visa Requirements||Yes|
Ever-changing laws and regulations are driving demand for regulatory affairs professionals who can help companies effectively bring medical 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 for Drugs, Biologics, and Medical Devices.
This unique graduate degree is designed to deepen your understanding of current regulations and their practical application in the development and commercialization of drugs, biologics, and medical device products. Regulatory affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the regulatory process. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a medical product to market, both in the U.S. and around the globe.
- Gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment
- Acquire the foundation necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, and clinical investigations
- Examine every step of the drug development and regulation process
- Sharpen your understanding of the laws that govern the development, manufacturing, and commercial distribution of drugs, biologics, and medical devices
- Analyze how emerging developments and trends are reshaping medical device regulations
Generally speaking, the pharmaceutical and medicine manufacturing industry is not highly sensitive to changes in economic conditions—consistently experiencing growth in both jobs and profits. Because they are relied upon to get new drugs and devices tested, approved, and put on the market, regulatory affairs specialists are continually in demand. While employment prospects are bright across the field, regulatory affairs professionals with the most education are likely to enjoy the most opportunities and highest pay.
ALIGN Master’s Degree Program
Interested in our Regulatory Affairs Program but think your background might not be a match? Consider our ALIGN program. Created specifically to prepare bachelor’s degree holders in STEM-related disciplines for high-demand industries, ALIGN offers custom curricula in hybrid formats on all our campuses and includes the benefits of our co-op experience and Northeastern’s global network. To learn more, visit our ALIGN website.
Interested in learning more? Watch one of our webinars:
Required Courses (25 q.h.)*
|RGA 6100||Introduction to Drug and Medical Device Regulation||4 q.h.|
|BTC 6210||Human Experimentation: Methodological Issues Fundamental to Clinical Trials||4 q.h.|
|RGA 6201||New Drug Development: A QA Regulatory Overview||4 q.h.|
|RGA 6202||Medical Device Development: A QA Regulatory Overview||4 q.h.|
|RGA 6200||Biologics Development: A QA Regulatory Overview||4 q.h.|
|RGA 6203||Food, Drug, and Medical Device Law: Topics and Cases
(This course should be taken as the final required course.)
*Please note: completion of RGA 6280: Advanced Writing on International Biomedical Topics may be required of students as a condition for their continued enrollment in this program.
Choose one of the following Safety and Surveillance courses (4 q.h.)
|BTC 6211||Validation and Auditing of Clinical Trial Information||4 q.h.|
|RGA 6212||Safety Sciences 1: Introduction to Safety and Surveillance||4 q.h.|
|RGA 6213||Safety Sciences 2: Safety Surveillance, Pharmacoepidemiology, Risk||4 q.h.|
|RGA 6230||Clinical Laboratory Management in Clinical Trials||4 q.h.|
|RGA 6280||Advanced Writing on International Biomedical Topics
Please note: completion of this course may be required of students as a condition for their continued enrollment in this program.
|TCC 6310||Regulatory Documentation Processes||4 q.h.|
|TCC 6370||Regulatory Writing: Medical Device Submissions||4 q.h.|
|TCC 6380||Regulatory Writing: New Drug Applications||4 q.h.|
|RGA 6233||Application of Quality System Regulation in Medical Device Design and Manufacturing||4 q.h.|
|RGA 6234||Drug and Device Supplier Risk Management: Compliance and Processes||4 q.h.|
Choose one of the following Business and Law courses (4 q.h.)
|BTC 6260||The Business of Medicine and Biotechnology||4 q.h.|
|RGA 6110||Understanding the Health-Care Landscape||4 q.h.|
|RGA 6214||Food and Drug Administration: Creation, Behavior, and Regulatory Culture||4 q.h.|
|RGA 6216||Medical, Social, and Financial Dimensions of Orphan Drugs||4 q.h.|
|RGA 6217||Biomedical Product Development: From Biotech to Boardroom to Market||4 q.h.|
|RGA 6218||Regulatory Affairs in an Entrepreneurial Environment||4 q.h.|
|RGA 6219||Advertising and Promotion of Drugs and Medical Device Products||4 q.h.|
|RGA 6235||Emerging Product Categories in the Regulation of Drugs and Biologics||4 q.h.|
Choose one of the following Development and Strategy courses (4 q.h.)
|BTC 6213||Clinical Trial Design Optimization and Problem Solving||4 q.h.|
|PMC 6212||Clinical Drug Development Data Analysis: Concepts||4 q.h.|
|RGA 6112||Biomedical Intellectual Property Management: Patents||4 q.h.|
|RGA 6205||Emerging Trends and Issues in the Medical Devices Industry||4 q.h.|
|RGA 6210||Strategic Planning and Project Management for Regulatory Affairs||4 q.h.|
|RGA 6211||Combination Products and Convergence||4 q.h.|
|RGA 6215||Project Management in Early Drug Discovery and Development||4 q.h.|
|RGA 6245||Regulation of Generic Pharmaceutical and Biosimilar Products||4 q.h.|
|RGA 6250||Financing and Reimbursement in Biomedical Product Development||4 q.h.|
Choose one of the following International courses (4 q.h.)
|RGA 6220||Global Biotechnology Product Registration: E.U., U.S. Product Regulation||4 q.h.|
|RGA 6221||European Union Compliance Process and Regulatory Affairs||4 q.h.|
|RGA 6222||European Medical Device Regulations||4 q.h.|
|RGA 6223||Global Awareness: Canada, Asian, and Latin American Regulatory Affairs||4 q.h.|
|RGA 6225||Japanese Medical Device Regulations and Registration||4 q.h.|
|RGA 6226||Canadian and Australian Medical Device Regulations||4 q.h.|
|RGA 6227||Global Awareness: Emerging Medical Device Markets||4 q.h.|
|RGA 6228||Managing International Clinical Trials||4 q.h.|
|RGA 6240||The Evolving Indian Regulatory Landscape||4 q.h.|
Open Electives (4 q.h.) - Some Suggested Topics:
Personal and Career Development
|INT 6943||Integrative Experiential Learning||3 q.h.|
|RGA 6206||Practical Aspects of Regulatory Compliance||4 q.h.|
|Or one course from any other category||4 q.h.|
Total Quarter Hours: 45
Attention: If you enrolled before Fall 2012, contact your student success specialist for your curriculum.
Below are the official Admissions Requirements for this program.
- Online application
- Statement of purpose (500-1000 words): identifying 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 resume: Current resume that displays job responsibilities, relevant experience, and education history
- Two letters of recommendation: from individual(s) 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 or life sciences
- Two to three years of work experience in the field can be substituted for a degree in pharmacy or life sciences
- Proof of English language proficiency: ONLY for students for whom English is not their primary language: English language proficiency guidelines
For general admissions information and recommended admissions deadlines, Graduate Admissions.
All requirements must be received prior to review.
Estimated total tuition for this program is $27,495.00.
Tuition for individual courses is based on the number of quarter hours. Most courses are 3-6 quarter hours. See Graduate Tuition Rates for details.
Use our Tuition Calculator below to see if transfer credit or tuition reimbursement from your employer could reduce your total tuition.
Please note: The estimated total tuition is based on tuition rates for Academic Year 2014-15 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.
*A maximum of 9 quarter hours of graduate- or doctoral-level credit obtained at another institution may be awarded as Advanced Graduate Credit to the Doctor of Education program.
Who Will Your Classmates Be?
This program is ideally suited for individuals who have experience in a health- or a science-related field and wish to gain a foothold in the growing field of regulatory affairs.
Upon graduation, students are qualified to pursue positions within drug, biologic, biotechnology, or medical device companies in the following areas:
- Research and development
- Clinical trials
- Premarket approvals
- Post-market surveillance
Job titles may include:
- Regulatory affairs specialist
- Assistant project manager
- Associate scientist
- Change control specialist
- Technical engineer
- Stability specialist
- Medical affairs associate
- Research associate
- Quality systems engineer
- Quality assurance associate
An undergraduate degree is required.
- Demonstrate the ability to proactively apply global regulatory knowledge and perspectives in a timely manner to professional cross-functional biomedical product commercialization teams through participation in group project work and instructor evaluation.
- Critically evaluate existing global pharmaceutical, biologic and medical device regulatory concepts through analysis of case studies, individual and peer group-based project work, and classroom or online presentation.
- Formulate tenable regulatory strategies for the commercialization of pharmaceutical, biologic and medical device products into each major global geographic market, and critically evaluate these strategies through oral and written presentations, examinations and instructor review within the context of coursework and a program capstone project.
- Create quality prototype pre- and post-commercialization sample documents that could be submitted to global regulatory agencies, including the Food and Drug Administration, European Medicines Agency, Brazilian ANVISA, Indian DCGI, Chinese FDA, and Japanese MHLW prior to graduating from the program.
- Critically and proactively analyze emerging technology trends from global regulatory and health economic perspectives, and utilize this analysis to develop novel regulations to ensure that such technologies can be commercialized safely and effectively, with pre-specified performance characteristics.
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