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.
Drexel University is transitioning to a semester calendar system as of Fall 2027. View the semester program of study for this program.
| 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 2026-2027, students enrolled in an online graduate academic program will be charged a graduate online program fee of $125 per year.
2026-2027 Academic Year
Term
Classes Begin
Classes End
Exams Begin
Exams End
Fall 2026
September 22, 2026
December 5, 2026
December 7, 2026
December 12, 2026
Winter 2027
January 4, 2027
March 13, 2027
March 15, 2027
March 20, 2027
Spring 2027
March 29, 2027
June 5, 2027
June 7, 2027
June 12, 2027
Summer 2027
June 21, 2027
August 7, 2027
August 9, 2027
August 14, 2027
2027-2028 Academic Year
Term
Classes Begin
Classes End
Exams Begin
Exams End
Fall 2027
August 23, 2027
December 8, 2027
December 13, 2027
December 17, 2027
Spring 2028
January 10, 2028
April 24, 2028
April 27, 2028
May 3, 2028
Summer 2028
May 15, 2028
August 5, 2028
August 7, 2028
August 11, 2028