Regulatory Affairs and Quality Assurance Master of Science

The Master of Science in Regulatory Affairs and Quality Assurance (RA and QA) in the School of Pharmacy at Temple University is designed for professionals in pharmaceutical, biopharmaceutical, medical device and related industries. The curriculum blends regulatory science with quality practices, teaching students how to interpret and apply the latest domestic and global regulations in their current industry career. This is a non-thesis MS program that can be completed in-person or online. 

Most RA and QA students work full time, so many pursue their degree on a part-time basis, taking one or two courses per term, conveniently scheduled on weeknights or weekends. It is also possible to complete the RA and QA MS on a full-time basis by taking three courses (nine credit hours) per semester. 

The program is designed so that students may earn a certificate before applying to the program. All courses earned in the certificate will count toward the master’s. 

Faculty members are specialists in many areas such as auditing; clinical trial management and operations; global regulation; IND/NDA submissions; manufacturing; pharmaceutical, food and device law; pharmaceutical labeling and advertising; quality assurance; regulatory affairs; and validation. 

Regulatory Affairs and Quality Assurance at the School of Pharmacy

The first university to develop a graduate program in quality assurance and regulatory affairs, Temple’s School of Pharmacy continues to set the gold standard in this dynamic professional discipline. Since 1968, the school has remained in the forefront of industry education, offering more courses in RA and QA than any other similar graduate program. Each year we continue to add and refine the curriculum to incorporate the latest trends in regulatory sciences. 

RA and QA courses expose students to real-world developments in the pharmaceutical industry, from current quality practices to the latest trends in domestic and global regulation. Throughout their course of study, RA and QA students gain a greater appreciation for benefit-risk assessment, regulatory intelligence, data mining and statistical relevance, and the complexities of blending pharmaceutical and regulatory science on a global scale. 

Most students work in industry, representing the world’s foremost pharmaceutical, device and biotechnology companies. Their experience and knowledge vary considerably: Some are just starting their careers, while others have been involved in industry for thirty years or more.  

With students and faculty drawn from more than 300 companies, the networking opportunities are tremendous. Each classroom experience coalesces the experiences of individuals from multiple aspects of the industry, including quality assurance and control, regulatory science, R&D, manufacturing and validation, clinical research and trials, medical affairs and pharmacovigilance, biotechnology and generic drugs, medical devices and combination products, and marketing and sales.  

Students from the cosmetic, chemical, healthcare and food industries also participate to gain a deeper understanding of quality practices and regulatory compliance. 

The pioneer in this educational discipline, the School of Pharmacy offers highly flexible and convenient scheduling options. Students may start or end the program in any semester (fall, spring or summer) and can also attend weeknight or weekend courses. All courses are available in an online format.

Certificate Programs 

In addition to the MS in RA and QA, students may pursue various certificate programs in RA and QA, almost all of which can also be pursued online. Certificates provide an excellent way for students to earn well-recognized credentials in a specific industry specialty. 

Students can 

• pursue individual courses to enhance their knowledge of a specific area;,  

• earn specific certificates to gain credentials in a specialty,

• pursue the MS, either concentrating their electives in a given specialty or selecting courses from multiple industry disciplines (quality, regulatory, clinical, pharmacovigilance, medical devices, etc.),  

• apply credits earned in a certificate toward the master’s, and 

• pursue additional advanced certificates after receiving the MS. 

Related Graduate Degrees

• Pharmaceutical Sciences PhD
• Doctor of Pharmacy (PharmD)

Related Graduate Certificates

• Basic Pharmaceutical Development
• Biopharmaceutical Manufacturing and RA
• Biosimilars and Generic Drugs
• Clinical Trial Management
• Drug Development
• Food RA and QA
• Global Pharmacovigilance: Benefit-Risk Assessment
• GMPs for the 21st Century
• Labeling, Advertising and Promotions
• Medical Devices

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates are the same, whether courses are online, on-campus, part of a certificate program or part of another master’s program at the School of Pharmacy.

Per course for Pennsylvania residents: $3,558
Per course for nonresidents: $4,425

Tuition rates at Temple University are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more.

You can view the full Cost of Attendance breakdown on the Student Financial Services website.

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