Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
Overview
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.
Program Objectives
- 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
Interested in learning more?
Attend the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices Webinar on May 23, 2012 at 1:00 PM EST.
Curriculum
Required Courses (24 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) |
4 q.h. |
*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 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 6112 | Biomedical Intellectual Property Management: Patents, Trademarks, Copyrights, Trade Secrets, and Technology Licensing | 4 q.h. |
| RGA 6214 | Food and Drug Administration: Creation, Behavior, and Regulatory Culture | 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 6218 | Regulatory Affairs in an Entrepreneurial Environment | 4 q.h. |
| RGA 6217 | Biomedical Product Development: From Biotech to Boardroom to Market | 4 q.h. |
| RGA 6240 | The Evolving Indian Regulatory Landscape | 4 q.h. |
| RGA 6235 | Emerging Product Categories in the Regulation of Drugs and Biologics | 4 q.h. |
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 6206 | Practical Aspects of Regulatory Compliance | 4 q.h. |
| RGA 6212 | Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad | 4 q.h. |
| TCC 6370 | Regulatory Writing: Medical Device Submissions | 4 q.h. |
| TCC 6380 | Regulatory Writing: New Drug Applications | 4 q.h. |
| TCC 6310 | Regulatory Documentation Processes | 4 q.h. |
| RGA 6219 | Advertising and Promotion of Drugs and Medical Device Products | 4 q.h. |
| RGA 6230 | Clinical Laboratory Management in Clinical Trials | 4 q.h. |
Choose from one of the following Development and Marketing courses (4 q.h.)
| BTC 6213 | Clinical Trial Design Optimization and Problem Solving | 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 Professionals in Domestic and International Markets | 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 6216 | Medical, Social, and Financial Dimensions of Orphan Drugs | 4 q.h. |
| PMC 6212 | Clinical Drug Development Data Analysis: Concepts and Applications | 4 q.h. |
| RGA 6228 | Managing International Clinical Trials | 4 q.h. |
| RGA 6245 | Regulation of Generic Pharmaceutical and Biosimilar Products | 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. |
4 q.h. |
Elective Courses - Some Suggested Topics:
| RGA 6213 | Safety Sciences 2: Safety Surveillance, Pharmacoepidemiology, and Risk Management in the U.S. and Abroad | 4 q.h. |
| RGA 6222 | Global Awareness: European Medical Device Regulations | 4 q.h. |
| RGA 6223 | Global Awareness: Introduction to Canadian, Asian, and Latin American Regulatory Affairs | 4 q.h. |
| RGA 6225 | Global Awareness: Japan Medical Device Regulations and Registrations | 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. |
| COP 6940 |
Personal and Career Development: Leadership in Practice
|
3 q.h. |
Total Quarter Hours: 40
What will your course sequence look like?
Many prospective students want to understand the order in which they should take courses, as well as when certain courses are offered. For a sample course schedule, please review the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices Course Sequence Map.
Admissions Requirements
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
- 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.
Tuition
Estimated total tuition for this program is $21,400.00.
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.
Tuition Calculator
Please note: The estimated total tuition is based on tuition rates for Academic Year 2011-12 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.
Student Profile
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
- Manufacturing
- Labeling
- Advertising
- Post-market surveillance
Job titles may include:
- Regulatory affairs specialist
- Assistant project manager
- Associate scientist
- Biotechnician
- Change control specialist
- Technical engineer
- Stability specialist
- Medical affairs associate
- Research associate
- Quality systems engineer
- Quality assurance associate
An undergraduate degree is required.
Career Outlook
Put Your Degree to Work
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.
Talk to an Enrollment Coach
We can walk you through your program options and the application process.
- Call Toll Free:
- 877.668.7727
- Email:
- Contact Us
Upcoming Academic Term Dates
-
Spring Term
April 9, 2012 (6- & 12-week classes)
May 21, 2012 (6-week classes) -
Summer Term
July 2, 2012 (8-, 6-, and 4- week classes)
July 30, 2012 (4-week classes)