Regulatory Science, MS
ASU Health - Clinical, Health, Quality, REGULATORY, Science
As the pharmaceutical and medical device industries expand, so does the demand for skilled regulatory science professionals. Join in the mission to ensure the safety and efficacy of life-changing products, from life-saving medicines to cutting-edge medical devices. This program will empower you to contribute to society, protect public health and drive innovation.
The Master of Science program in regulatory science is designed for students interested in protecting public health through the discovery, development and marketing of medical products to the consumer. In particular, this program focuses on maintaining compliance regulations for drugs and devices, with an emphasis on safety, quality and performance. Students are prepared for careers in the pharmaceutical, medical research and medical device industries.
While earning the MS in regulatory science, students delve into all aspects of regulatory affairs, including:
- clinical research
- drug and medical device development
- ethical and legal aspects
- global regulatory practices
- manufacturing
- regulatory submissions
The field of regulatory science focuses on the application of regulations throughout the life cycle of medical products and compliance with regulations in the development, approval and marketing of medical products. This advanced degree incorporates a transdisciplinary approach to meet the unique needs of regulating bodies and the industry.
- College/school:
Edson College of Nursing and Health Innovation
- Location: Downtown Phoenix or Online
- STEM-OPT extension eligible: No
33 credit hours including the required applied project course (HCR 593)
Required Core (18 credit hours)
HCR 553 Quality Assurance and Clinical Research (3)
HCR 561 Responsible Conduct of Clinical Research (3)
HCR 563 Fundamentals of Regulatory Affairs (3)
HCR 576 Drug Discovery, Development and Regulations (3)
HCR 577 Global Regulatory Affairs (3)
HCR 578 Legal Aspects of Clinical Research (3)
Restricted Electives (12 credit hours)
HCR 552 Medical Device Development and Regulation (3)
HCR 555 Pharmaceutical Safety and Risk Management (3)
HCR 557 Clinical Research Design and Methods (3)
HCR 558 Technical Writing for the Regulatory Professional (3)
HCR 564 Global Regulatory Affairs Leadership (3)
HCR 568 Health Care Project Management (3)
HCR 575 Management and Negotiation of Clinical Trial Budgets and Contracts (3)
HCR 579 Translational Research in Drug Discovery and Development (3)
Culminating Experience (3 credit hours)
HCR 593 Applied Project (3)
Additional Curriculum Information
For electives coursework, students choose four courses for 12 credit hours from the restricted electives list. Other coursework may be substituted with approval from the academic unit.
Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.
Applicants are eligible to apply to the program if they have earned a bachelor's or master's degree from a nationally recognized, regionally accredited academic institution.
Applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in the last 60 hours of their first bachelor's degree program or a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in an applicable master's degree program.
All applicants must submit:
- graduate admission application and application fee
- official transcripts
- resume or curriculum vitae
- two online recommendations
- personal statement
- proof of English proficiency
Additional Application Information
An applicant whose native language is not English must provide proof of English proficiency regardless of their current residency.
The online references should be from professional colleagues, supervisors, professors or other professional contacts and should attest to the applicant's academic and leadership experiences.
ASU offers this program in an online format with multiple enrollment sessions throughout the year. Applicants may view the program’s ASU Online page for program descriptions and to request more information.
| Session | Modality | Deadline | Type |
|---|---|---|---|
| Session A/C | In Person | 07/19 | Final |
| Session A/C | In Person | 05/01 | Priority |
| Session | Modality | Deadline | Type |
|---|---|---|---|
| Session A/C | In Person | 12/01 | Final |
The field of regulatory affairs continues to grow as pharmaceutical and medical development advances. Companies are eager to hire regulatory science professionals into jobs such as:
- compliance officer
- FDA inspector
- quality assurance specialist
- quality control specialist
- regulatory affairs specialist
- regulatory coordinator
- regulatory manager
- regulatory scientist
Edson College of Nursing and Health Innovation
|
MERCC 250
regulatoryscience@asu.edu
602-496-0937
3 year programs
These programs allow students to fast-track their studies after admission and earn a bachelor's degree in three years or fewer while participating in the same high-quality educational experience of a 4-year option. Students should talk to their academic advisor to get started.
Accelerated master's
These programs allow students to accelerate their studies to earn a bachelor's plus a master's degree in as few as five years (for some programs).
Each program has requirements students must meet to be eligible for consideration. Acceptance to the graduate program requires a separate application. Students typically receive approval to pursue the accelerated master’s during the junior year of their bachelor's degree program. Interested students can learn about eligibility requirements and how to apply.
