Drexel University Kline School of Law’s online Graduate Certificate in Pharmaceutical and Medical Device Regulatory Compliance is designed for those who need a comprehensive knowledge of the legal, regulatory, and ethical frameworks surrounding the field of pharmaceutical and medical device manufacturing, marketing, and sales. The program combines a core curriculum of legal compliance, risk assessment, and data privacy with an in-depth study of how industry regulators (like the Food and Drug Administration) approach regulation around the research, development, sales, and marketing of pharmaceuticals, biologics, and medical devices.
The goal of a graduate certificate in regulatory affairs is to help you gain a working knowledge of the legal and compliance frameworks of a specific industry. This online program is designed to help you navigate the complex regulatory world of the pharmaceutical and medical device industry. The core courses of the five-course, 15-credit certificate cover compliance foundational skills such as auditing, investigation, and risk management. You can then choose three electives on topics such as Food and Drug Law, Information Privacy Law, or Legal Regulations of Pharmaceutical and Medical Device Sales and Marketing Practices.
Learn more about the program by completing the Request More Information form.
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The Kline School of Law certificate program prepares you for roles throughout the pharmaceutical and medical device industry. Common job titles within this field include:
Salary expectations for roles within the pharmaceutical and medical device industry vary based on exact titles, locations, etc. However, here are some common salaries and job titles to give you an idea of what to expect:
Position
2018 Median Salary*
Clinical Research Coordinator
$123,860
Compliance Officer
$68,860
Medical Device Sales Representative
$79,680
Pharmaceutical Sales Representative
$79,680
Regulatory Affairs Manager
$107,480
Regulatory Affairs Specialist
$68,860
*Data from O*Net
State restrictions may apply to some programs.
This program is organized into four 10-week quarters per year (as opposed to the traditional two semester system) which means you can take more courses in a shorter time period. One semester credit is equivalent to 1.5 quarter credits.
| Required Courses | ||
| LSTU 551 | Compliance Skills: Auditing, Investigation & Reporting | 4.0 |
| LSTU 554 | Risk Assessment and Management | 4.0 |
| Choose three: | 12.0 | |
|
LSTU 555
|
Compliance Communications | |
|
LSTU 570
|
Health Care Fraud: Regulation, Investigation, and Enforcement | |
|
LSTU 571
|
Legal Issues for Artificial Intelligence in Healthcare | |
|
LSTU 602
|
Patients and Privacy: HIPAA and Related Regulations | |
|
LSTU 603
|
Legal Regulation of Pharmaceutical and Medical Device Research and Development | |
|
LSTU 604
|
Legal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices | |
|
LSTU 605
|
Food and Drug Law | |
|
LSTU 660
|
Information Privacy Law | |
|
LSTU 661
|
The Law and Strategies Surrounding Cybersecurity | |
|
LSTU 662
|
European Union Data Privacy and Protection | |
| Total Credits | 20.0 | |
With multiple ways to submit documents, Drexel makes it easy to complete your application. Learn more by visiting our Completing Your Application Guide.
For the academic year 2025-2026, students enrolled in an online graduate academic program will be charged a graduate online program fee of $125 per year.
2025-2026 Academic Year
Term
Classes Begin
Classes End
Exams Begin
Exams End
Fall 2025
September 22, 2025
December 6, 2025
December 8, 2025
December 13, 2025
Winter 2026
January 5, 2026
March 14, 2026
March 16, 2026
March 21, 2026
Spring 2026
March 30, 2026
June 6, 2026
June 8, 2026
June 13, 2026
Summer 2026
June 22, 2026
August 29, 2026
August 31, 2026
September 5, 2026