Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

Campus Locations Boston, Online, Charlotte, Seattle
Also available 100% Online Yes
Other Format(s)
Credits Required for Graduation 45
Entry Terms Fall Quarter, Winter Quarter, Spring Quarter, Summer Quarter
Meets International Visa Requirements Yes

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.

Northeastern’s MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices offers students the opportunity to meet their career goals in the fields of regulatory affairs -- such as operational and strategic regulatory affairs, clinical regulatory affairs, and regulatory compliance -- by focusing their education in one of six unique concentrations that span the entire discipline. Concentration offerings include:

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

Career Outlook

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.


Curriculum

The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices offers students the opportunity to meet their career goals in the fields of regulatory affairs -- such as operational and strategic regulatory affairs, clinical regulatory affairs, and regulatory compliance -- by focusing their education in one of six unique concentrations that span the entire discipline. 

Students choose one of the following concentrations:

Operational Regulatory Affairs Concentration


Purpose: Provide practical knowledge in strategizing and compiling regulatory filings in the U.S. and major markets (E.U. and Canada)


Required Courses (29 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A Regulatory Overview  4 q.h. 
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases 5 q.h.
TCC 6370 Regulatory Writing: Medical Device Submissions 4 q.h.
TCC 6380 Regulatory Writing: New Drug Applications
4 q.h.


Required Electives (12 q.h.)

Students must earn a minimum of 12 quarter hours by choosing at least one course from each category.

Regulatory and Clinical Operations
RGA 6280 Advanced Writing on International Biomedical Topics 4 q.h.
TCC 6310 Regulatory Documentation Processes 4 q.h.
RGA 6212 Safety Sciences 1: Introduction to Safety and Surveillance 4 q.h.
BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamentals 4 q.h. 

 

Regulatory Perspective: Product Development, Business and Strategy
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6205 Emerging Trends and Issues in the Medical Device Industry  4 q.h. 
RGA 6210  Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products  4 q.h. 
RGA 6211  Combination Products and Convergence  4 q.h. 
RGA 6112  Biomedical Intellectual Property Management: Patents  4 q.h. 

 

International
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 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 Introduction to Canadian, 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. 

 

Open Elective (4 q.h.)

Students must earn a minimum of 4 quarter hours by choosing an RGA program elective from the following options:

COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
  • Students must also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement
  • Students must complete two of the following four courses prior to enrolling in COP 6940: RGA 6100, RGA 6201, RGA 6202, or BTC 6210
3 q.h.
INT 6943 Integrative Experiential Learning 3 q.h. 
  Or one additional course from this program 4 q.h.

 

Strategic Regulatory Affairs Concentration


Purpose:  Provide philosophy and methodologies to support life science companies’ business objectives with regulatory strategy and support it with clinical strategy. Provide methodologies to align regulatory and clinical strategies to product approvals, health economics, reimbursement, etc. 

Required Courses (21 q.h.)

RGA 6201 New Drug Development: A Regulatory Overview 4 q.h.
RGA 6202 Medical Device Development: A Regulatory Overview 4 q.h.
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6203  Food, Drug, and Medical Device Law: Topics and Cases  5 q.h. 
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h.


Required Electives (20 q.h.)

Students must earn a minimum of 20 quarter hours by choosing at least one course from each category.

Regulatory and Clinical Operations
RGA 6280 Advanced Writing on International Biomedical Topics 4 q.h.
RGA 6212 Safety Sciences 1: Introduction to Safety and Surveillance 4 q.h.
BTC 6211 Validation and Auditing of Clinical Trial Information  4 q.h. 
BTC 6213 Clinical Trial Design Optimization and Problem Solving 4 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamental to Clinical Trials 4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6216  Medical, Social, and Financial Dimensions of Orphan Drugs  4 q.h. 
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6112 Biomedical Intellectual Property Management: Patents 4 q.h. 
RGA 6205  Emerging Trends and Issues in the Medical Device Industry  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. 
RGA 6210  Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6211  Combination Products and Convergence  4 q.h. 

 

International
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 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 Introduction to Canadian, 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. 

 

Open Elective (4 q.h.)

Students must earn a minimum of 4 quarter hours by choosing an RGA program elective from the following options:

COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
  • Students must also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement
  • Students must complete two of the following four courses prior to enrolling in COP 6940: RGA 6100, RGA 6201, RGA 6202, or BTC 6210
3 q.h.
INT 6943 Integrative Experiential Learning 3 q.h. 
  Or any additional course from this program 4 q.h.

 

Clinical Research Regulatory Affairs Concentration 


Purpose:  Provide practical knowledge of regulatory requirements and methodologies for clinical human and animal research to support product development.

Required Courses (25 q.h.)

RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A Regulatory Overview  4 q.h. 
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases 5 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamental to Clinical Trials 4 q.h.
BTC 6213 Clinical Trial Design Optimization and Problem Solving  4 q.h. 

 

Required Electives (16 q.h.)

Students must earn a minimum of 16 quarter hours by choosing at least one course from each elective category.

Regulatory and Clinical Operations
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 6230 Clinical Laboratory Management in Clinical Trials 4 q.h. 
TCC 6310 Regulatory Documentation Processes 4 q.h. 
RGA 6280 Advanced Writing on International Biomedical Topics  4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260  The Business of Medicine and Biotechnology 4 q.h. 
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market  4 q.h. 
RGA 6215 Project Management in Early Drug Discovery and Development 4 q.h. 
RGA 6210  Strategic Planning and Project Management for Regulatory Affairs  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. 
RGA 6211 Combination Products and Convergence 4 q.h. 

 

International
RGA 6228 Managing International Clinical Trials 4 q.h. 
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 q.h.
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h. 
RGA 6223  Introduction to Canadian, Asian, and Latin American Regulatory Affairs  4 q.h. 

  

Open Elective (4 q.h.)


Students must earn a minimum of 4 quarter hours by choosing an RGA program elective from the following options:

COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
  • Students must also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement
  • Students must complete two of the following four courses prior to enrolling in COP 6940: RGA 6100, RGA 6201, RGA 6202, or BTC 6210
3 q.h.
INT 6943 Integrative Experiential Learning 3 q.h. 
  Or any additional course from this program 4 q.h.

 

International Regulatory Affairs Concentration


Purpose:  Provide practical knowledge on the process of international registrations of life science products, methods of international regulatory and clinical filings.

Required Courses (25 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A Regulatory Overview  4 q.h. 
RGA 6200 Biologics Development: A Regulatory Overview  4 q.h. 
RGA 6220
Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 q.h.
RGA 6223
Introduction to Canadian, Asian, and Latin American Regulatory Affairs 4 q.h.


Required Electives (16 q.h.)

Students must earn a minimum of 16 quarter hours by choosing at least one course from each elective category.

Regulatory and Clinical Operations
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.
BTC 6213 Clinical Trial Design Optimization and Problem Solving 4 q.h.
TCC 6370 Regulatory Writing: Medical Device Submissions 4 q.h. 
TCC 6380 Regulatory Writing: New Drug Applications  4 q.h. 
RGA 6280 Advanced Writing on International Biomedical Topics 4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases 5 q.h.
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h.
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6205 Emerging Trends and Issues in the Medical Device Industry 4 q.h. 
RGA 6210  Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products 4 q.h. 
RGA 6211 Combination Products and Convergence 4 q.h. 

  

International
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h.
RGA 6222 European Medical Device Regulations 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 6211 Combination Products and Convergence 4 q.h.

 

Open Elective (4 q.h.)

Students must earn a minimum of 4 quarter hours by choosing an RGA program elective from the following options.

COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
  • Students must also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement
  • Students must complete two of the following four courses prior to enrolling in COP 6940: RGA 6100, RGA 6201, RGA 6202, or BTC 6210
3 q.h.
INT 6943 Integrative Experiential Learning 3 q.h. 
  Or any additional course from this program 4 q.h.

  

Regulatory Compliance Concentration


Purpose: Provide in-depth practical knowledge of regulatory compliance of life science manufacturing (including CMC – Chemistry, Manufacturing, & Controls) and Quality System practices.


Required Courses (25 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview  4 q.h. 
RGA 6202 Medical Device Development: A 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 5 q.h.
RGA 6206 Practical Aspects of Regulatory Compliance 4 q.h.


Required Electives (16 q.h.)

Students must earn a minimum of 16 quarter hours by choosing at least one course from each elective category:

Regulatory and Clinical Operations
RGA 6212 Safety Sciences 1: Introduction to Safety and Surveillance 4 q.h.
BTC 6213 Clinical Trial Design Optimization and Problem Solving 4 q.h.
BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h. 
RGA 6230 Clinical Laboratory Management in Clinical Trials 4 q.h.
RGA 6234 Drug and Device Supplier Risk Management: Compliance and Processes 4 q.h. 
RGA 6280 Advanced Writing on International Biomedical Topics  4 q.h. 

 

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h.
RGA 6235 Emerging Product Categories in the Regulation of Drugs and Biologics 4 q.h.
RGA 6210 Strategic Planning and Project Management for Regulatory Affairs  4 q.h. 
RGA 6245  Regulation of Generic Pharmaceutical and Biosimilar Products 4 q.h. 
RGA 6205  Emerging Trends and Issues in the Medical Device Industry  4 q.h. 
RGA 6211  Combination Products and Convergence 4 q.h. 

International
RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h.
RGA 6222 European Medical Device Regulations 4 q.h.
RGA 6223 Introduction to Canadian, 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. 

 

Open Elective (4 q.h.)

Students must earn a minimum of 4 quarter hours by choosing an RGA program elective from the following options:

COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
  • Students must also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement
  • Students must complete two of the following four courses prior to enrolling in COP 6940: RGA 6100, RGA 6201, RGA 6202, or BTC 6210
3 q.h.
INT 6943 Integrative Experiential Learning 3 q.h. 
  Or any additional course from this program 4 q.h.

 

General Regulatory Affairs Concentration


Purpose: Provide general knowledge of regulatory profession.

Required Courses (25 q.h.)

RGA 6100 Introduction to Drug and Medical Device Regulations 4 q.h.
BTC 6210 Human Experimentation: Methodological Issues Fundamentals 4 q.h.
RGA 6201 New Drug Development: A Regulatory Overview 4 q.h. 
RGA 6202  Medical Device Development: A 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.
5 q.h. 

 

Required Electives (16 q.h.)

Students must earn a minimum of 16 quarter hours by choosing at least one course from each elective category:

Regulatory and Clinical Operations
BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h.
BTC 6213 Clinical Trial Design Optimization and Problem Solving  4 q.h. 
RGA 6212 Safety Sciences 1: Introduction to Safety and Surveillance 4 q.h.
RGA 6230 Clinical Laboratory Management in Clinical Trials 4 q.h.
RGA 6280 Advanced Writing on International Biomedical Topics
4 q.h.
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.

Regulatory Perspective: Product Development, Business, and Strategy
BTC 6260 The Business of Medicine and Biotechnology 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 6219 Advertising and Promotion of Drugs and Medical Device Products 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 6245  Regulation of Generic Pharmaceutical and Biosimilar Products  4 q.h. 
RGA 6250  Financing and Reimbursement in Biomedical Product Development  4 q.h. 

 

International
RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 5 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 Introduction to Canadian, 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.


Open Elective (4 q.h.)

Students must earn a minimum of 4 quarter hours by choosing an RGA program elective from the following options:

COP 6940 Personal and Career Development
  • Enrollment in COP 6940 requires participation in the cooperative education program (subject to availability)
  • Students must also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement
  • Students must complete two of the following four courses prior to enrolling in COP 6940: RGA 6100, RGA 6201, RGA 6202, or BTC 6210
3 q.h.
INT 6943 Integrative Experiential Learning 3 q.h.
  Or one additional course from this program 4 q.h.


Total Quarter Hours: 45


Attention:
If you enrolled before Fall 2012, contact your student success specialist for your curriculum.

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: Reflecting a degree in pharmacy or life sciences
    • Two to 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

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 $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.

Tuition Calculator

Degree Type




Go


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.


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.


Learning Outcomes

Learning Outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Request Information

Apply now
Quick Links

Talk to an Enrollment Representative

We can walk you through your program options and the application process.

Call Toll Free: 877.668.7727

Email: Contact Us

Live Chat: Chat Now
(Available Monday through Friday,
9:00am to 4:30pm ET.)

Next Term Starts
  • Spring Term
    Apr 6, 2015 (12- and 6-week classes)
    May 18, 2015 (6-week classes)

Academic Calendar

©