Regulatory Affairs for Drugs, Biologics, and Medical Devices

Degree:
Location: Anywhere

Why Regulatory Affairs?

The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program is designed to produce graduates who are highly qualified to manage the regulatory process for companies innovating and developing cutting edge products in science and medicine.

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 online 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. Delivered entirely online, graduate courses address critical regulatory issues affecting all of the stages and processes required to bring medical products to the market in the U.S. and around the world.

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:

  • Operational Regulatory Affairs
  • Strategic Regulatory Affairs
  • Clinical Research Regulatory Affairs
  • International Regulatory Affairs
  • Regulatory Compliance
  • General Regulatory Affairs

More Details

Unique Features

  • Students can focus on one of six 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
  • Online Program provides flexibility and interactive experience for working professionals

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 global biomedical product commercialization regulations

 


What you'll study

Concentrations

Concentration in Clinical Research Regulatory Affairs

45 total quarter hours required.


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

Required Courses

RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6207 - FDA and the Electronic Common Technical Document (eCTD)
4.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00
BTC 6213 - Clinical Trial Design Optimization and Problem Solving
4.00
RGA 6300 - Practical Applications in Biomedical Product Global Regulatory Affairs
4.00

Required Electives

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

Regulatory and Clinical Operations

Complete at least one of the following:

RGA 6208: Operational Aspects of Electronic Common Technical Document (eCTD) Submissions

BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6001 - Introduction to Food and Drug Administration Medical Device Regulation
2.00
RGA 6212 - Introduction to Safety Sciences
4.00
RGA 6230 - Clinical Laboratory Management in Clinical Trials
4.00
RGA 6310 - Regulatory Documentation Processes
4.00

Regulatory Perspective: Product Development, Business, and Strategy

Complete at least one of the following:

BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6235 - Emerging Product Categories in the Regulation of Drugs and Biologics
4.00
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
4.00
RGA 6215 - Project Management in Early Drug Discovery and Development
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
4.00
RGA 6250 - Financing and Reimbursement in Biomedical Product Development
4.00
RGA 6211 - Combination Products and Convergence
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00
INT 6943 - Integrative Experiential Learning
3.00
RGA 6920 - Internship Reflection
1.00

(Enrollment in COP 6940 or INT 6943 requires participation in the cooperative education program [subject to availability].)

International

Complete at least one of the following

RGA 6228 - Managing International Clinical Trials
4.00
RGA 6220 - Global Biotechnology Product Registration: E.U., U.S. Product Regulation
5.00
RGA 6221 - European Union Compliance Process and Regulatory Affairs
4.00
RGA 6223 - Introduction to Canadian, Asian, and Latin American Regulatory Affairs
4.00
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
4.00
Concentration in General Regulatory Affairs

45 total quarter hours required.

Purpose: Provide general knowledge of regulatory profession.

Required Courses

RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6207 - FDA and the Electronic Common Technical Document (eCTD)
4.00
RGA 6300 - Practical Applications in Biomedical Product Global Regulatory Affairs
4.00

Required Electives

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

Regulatory and Clinical Operations

Complete at least one of the following:

BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
BTC 6213 - Clinical Trial Design Optimization and Problem Solving
4.00
RGA 6212 - Introduction to Safety Sciences
4.00
RGA 6230 - Clinical Laboratory Management in Clinical Trials
4.00
RGA 6310 - Regulatory Documentation Processes
4.00
RGA 6370 - Regulatory Writing: Medical Device Submissions
4.00
RGA 6380 - Regulatory Writing: New Drug Applications
4.00
RGA 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
4.00
RGA 6234 - Drug and Device Supplier Risk Management: Compliance and Processes
4.00

RGA 6208: Operational Aspects of Electronic Common Technical Document (eCTD) Submissions

Regulatory Perspective: Product Development, Business, and Strategy

Complete at least one of the following:

BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6215 - Project Management in Early Drug Discovery and Development
4.00
RGA 6216 - The Medical, Social, and Financial Dimensions of Orphan Drugs
4.00
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
4.00
RGA 6219 - The Advertising and Promotion of Drug and Medical Device Products
4.00
PMC 6212 - Clinical Drug Development Data Analysis: Concepts
4.00
RGA 6112 - Biomedical Intellectual Property Management: Patents
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6211 - Combination Products and Convergence
4.00
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
4.00
RGA 6250 - Financing and Reimbursement in Biomedical Product Development
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00
INT 6943 - Integrative Experiential Learning
3.00
RGA 6920 - Internship Reflection
1.00

(Enrollment in COP 6940 or INT 6943 requires participation in the cooperative education program [subject to availability].)

International

Complete at least one of the following

RGA 6220 - Global Biotechnology Product Registration: E.U., U.S. Product Regulation
5.00
RGA 6221 - European Union Compliance Process and Regulatory Affairs
4.00
RGA 6222 - European Medical Device Regulations
4.00
RGA 6223 - Introduction to Canadian, Asian, and Latin American Regulatory Affairs
4.00
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
RGA 6227 - Emerging Medical Device Markets
4.00
RGA 6228 - Managing International Clinical Trials
4.00
Concentration in International Regulatory Affairs

45 total quarter hours required.


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

Required Courses

RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
RGA 6207 - FDA and the Electronic Common Technical Document (eCTD)
4.00
RGA 6220 - Global Biotechnology Product Registration: E.U., U.S. Product Regulation
5.00
RGA 6223 - Introduction to Canadian, Asian, and Latin American Regulatory Affairs
4.00
RGA 6300 - Practical Applications in Biomedical Product Global Regulatory Affairs
4.00

Required Electives

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

Regulatory and Clinical Operations

Complete at least one of the following:

BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
BTC 6213 - Clinical Trial Design Optimization and Problem Solving
4.00
RGA 6212 - Introduction to Safety Sciences
4.00
RGA 6370 - Regulatory Writing: Medical Device Submissions
4.00
RGA 6380 - Regulatory Writing: New Drug Applications
4.00

RGA 6208: Operational Aspects of Electronic Common Technical Document (eCTD) Submissions

Regulatory Perspective

Complete at least one of the following:

RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
4.00
RGA 6235 - Emerging Product Categories in the Regulation of Drugs and Biologics
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
4.00
RGA 6211 - Combination Products and Convergence
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00
INT 6943 - Integrative Experiential Learning
3.00
RGA 6920 - Internship Reflection
1.00

(Enrollment in COP 6940 or INT 6943 requires participation in the cooperative education program [subject to availability].)

International

Complete at least one of the following

RGA 6221 - European Union Compliance Process and Regulatory Affairs
4.00
RGA 6222 - European Medical Device Regulations
4.00
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
RGA 6227 - Emerging Medical Device Markets
4.00
RGA 6228 - Managing International Clinical Trials
4.00
RGA 6229 - Biomedical Product Regulatory Affairs in Emerging Markets: Russia and Kazakhstan
4.00
RGA 6211 - Combination Products and Convergence
4.00
Concentration in Operational Regulatory Affairs

45 total quarter hours required.

Required Courses

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

RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6207 - FDA and the Electronic Common Technical Document (eCTD)
4.00
RGA 6370 - Regulatory Writing: Medical Device Submissions
4.00
RGA 6380 - Regulatory Writing: New Drug Applications
4.00
RGA 6300 - Practical Applications in Biomedical Product Global Regulatory Affairs
4.00

RGA 6208: Operational Aspects of Electronic Common Technical Document (eCTD) Submissions

Required Electives

Students must earn a minimum of 8 quarter hours by choosing at least two courses from the lists below.

Regulatory and Clinical Operations

RGA 6280 - Advanced Writing on International Biomedical Topics
4.00
RGA 6310 - Regulatory Documentation Processes
4.00
RGA 6212 - Introduction to Safety Sciences
4.00
BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00

Regulatory Perspective: Product Development, Business, and Strategy

BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6235 - Emerging Product Categories in the Regulation of Drugs and Biologics
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
4.00
RGA 6211 - Combination Products and Convergence
4.00
RGA 6112 - Biomedical Intellectual Property Management: Patents
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00
INT 6943 - Integrative Experiential Learning
3.00
RGA 6920 - Internship Reflection
1.00

(Enrollment in COP 6940 or INT 6943 requires participation in the cooperative education program [subject to availability].)

International

RGA 6220 - Global Biotechnology Product Registration: E.U., U.S. Product Regulation
5.00
RGA 6221 - European Union Compliance Process and Regulatory Affairs
4.00
RGA 6222 - European Medical Device Regulations
4.00
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
4.00
RGA 6223 - Introduction to Canadian, Asian, and Latin American Regulatory Affairs
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
Concentration in Regulatory Compliance

45 total quarter hours required.

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

Required Courses

RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6207 - FDA and the Electronic Common Technical Document (eCTD)
4.00
RGA 6300 - Practical Applications in Biomedical Product Global Regulatory Affairs
4.00

Required Electives

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

Regulatory and Clinical Operations

Complete at least one of the following:

RGA 6212 - Introduction to Safety Sciences
4.00
BTC 6213 - Clinical Trial Design Optimization and Problem Solving
4.00
BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
RGA 6230 - Clinical Laboratory Management in Clinical Trials
4.00
RGA 6234 - Drug and Device Supplier Risk Management: Compliance and Processes
4.00
 

RGA 6208: Operational Aspects of Electronic Common Technical Document (eCTD) Submissions

Regulatory Perspective: Product Development, Business, and Strategy

Complete at least one of the following:

BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
4.00
RGA 6235 - Emerging Product Categories in the Regulation of Drugs and Biologics
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
4.00
RGA 6211 - Combination Products and Convergence
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00
INT 6943 - Integrative Experiential Learning
3.00
RGA 6920 - Internship Reflection
1.00

(Enrollment in COP 6940 or INT 6943 requires participation in the cooperative education program [subject to availability].)

International

Complete at least one of the following

RGA 6221 - European Union Compliance Process and Regulatory Affairs
4.00
RGA 6222 - European Medical Device Regulations
4.00
RGA 6223 - Introduction to Canadian, Asian, and Latin American Regulatory Affairs
4.00
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
Concentration in Strategic Regulatory Affairs

45 total quarter hours required.

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. 

Special Admission Requirement: The content of this concentration is designed for seasoned regulatory professionals and expects basic knowledge of the field. As such, successful applicants should have at least 3-4 years of direct experience in a regulatory affairs-related position.

Required Courses

RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6207 - FDA and the Electronic Common Technical Document (eCTD)
4.00
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
4.00
RGA 6300 - Practical Applications in Biomedical Product Global Regulatory Affairs
4.00

Required Electives

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

Regulatory and Clinical Operations

Complete one of the following:

RGA 6212 - Introduction to Safety Sciences
4.00
BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
BTC 6213 - Clinical Trial Design Optimization and Problem Solving
4.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00

RGA 6208: Operational Aspects of Electronic Common Technical Document (eCTD) Submissions

Regulatory Perspective: Product Development, Business, and Strategy

Complete one of the following:

BTC 6260 - The Business of Medicine and Biotechnology
4.00
RGA 6216 - The Medical, Social, and Financial Dimensions of Orphan Drugs
4.00
RGA 6235 - Emerging Product Categories in the Regulation of Drugs and Biologics
4.00
RGA 6112 - Biomedical Intellectual Property Management: Patents
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
4.00
RGA 6245 - Regulation of Generic Pharmaceutical and Biosimilar Products
4.00
RGA 6250 - Financing and Reimbursement in Biomedical Product Development
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6211 - Combination Products and Convergence
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00
INT 6943 - Integrative Experiential Learning
3.00
RGA 6920 - Internship Reflection
1.00

(Enrollment in COP 6940 or INT 6943 requires participation in the cooperative education program [subject to availability].)

International

Complete one of the following

RGA 6220 - Global Biotechnology Product Registration: E.U., U.S. Product Regulation
5.00
RGA 6221 - European Union Compliance Process and Regulatory Affairs
4.00
RGA 6222 - European Medical Device Regulations
4.00
RGA 6223 - Introduction to Canadian, Asian, and Latin American Regulatory Affairs
4.00
RGA 6224 - Regulation of Biomedical Product Commercialization by Health Canada
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
RGA 6227 - Emerging Medical Device Markets
4.00
Concentration in Medical Device Regulatory Affairs

45 total quarter hours required.

Required Courses

RGA 6001 - Introduction to Food and Drug Administration Medical Device Regulation
2.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00
RGA 6202 - Medical Device Development: A Regulatory Overview
4.00
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6370 - Regulatory Writing: Medical Device Submissions
4.00
RGA 6300 - Practical Applications in Biomedical Product Global Regulatory Affairs
4.00

RGA 6300 must be taken as the last course in the program.

Required Electives

Students must earn a minimum of 22 quarter hours by choosing at least one course from each elective category.

Regulatory and Clinical Operations

RGA 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
4.00
RGA 6234 - Drug and Device Supplier Risk Management: Compliance and Processes
4.00

Regulatory Perspective: Product Development, Business, and Strategy

RGA 6219 - The Advertising and Promotion of Drug and Medical Device Products
4.00
RGA 6112 - Biomedical Intellectual Property Management: Patents
4.00
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6211 - Combination Products and Convergence
4.00
COP 6940 - Personal and Career Development
3.00 - 4.00

(Enrollment in COP 6940 requires participation in the cooperative education program [subject to availability].)

INT 6943 - Integrative Experiential Learning
3.00

Students may also take RGA 6920 (1 q.h.) to meet the 4 q.h. elective course requirement

International

RGA 6222 - European Medical Device Regulations
4.00
RGA 6225 - Japanese Medical Device Regulations and Registration
4.00
RGA 6226 - Canadian and Australian Medical Device Regulations
4.00
RGA 6227 - Emerging Medical Device Markets
4.00

RGA 6241  Challenges & Opportunities for Working in Multicultural Environments  2 q.h.

RGA 6247   Medicines Regulatory Harmonization in Africa  2 q.h.

Special Topics

RGA 6243  Medical Device Product Development in Canada  4 q.h.

RGA 6460  Creating and Safeguarding Intellectual Property in the Life Sciences: How Regulatory Affairs Can Help  2 q.h.

RGA 6420  Global IVD Regulations & Submissions  4 q.h.

RGA 6242  E.U. Medical Device Clinical Evaluations 2  q.h.

Did You Know?

137,000 new regulatory affairs jobs will need to be filled by 2018.

Did You Know?

68% of regulatory professionals pursue graduate studies.

Average Time to Completion

1-2 Years

Commitment

Full-Time
Part-Time

Entry Terms

Fall
Spring
Summer
Winter

Visa Eligible

No