Master of Science in Pharmaceutical Regulatory Sciences

The Master of Science in Pharmaceutical Regulatory Sciences in the School of Pharmacy at Temple University addresses the immediate need for professionals well versed in regulatory science. The curriculum offers courses from pharmaceutical science and regulatory affairs (RA) and quality assurance (QA), bridging the gaps in knowledge that often exist between these areas. This master of science degree is part of the RA and QA graduate program.

What is regulatory science?

The Food and Drug Administration (FDA) defines regulatory science as the “science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-related products.” Both regulated industry and regulatory agencies need professionals who understand the complex integration of regulations, quality practices and scientific knowledge required to bring regulated healthcare products to market. 

Pharmaceutical science courses focus on the core science principles involved in the development and manufacturing of therapeutic products. RA and QA courses provide a strong framework of regulations and quality practices, addressing scientific methods needed to assure safety, efficacy, quality and consistent performance. 

The curriculum draws upon the school’s world-renowned MS program in RA and QA. Courses are taught by pharmaceutical scientists actively engaged in research as well as industry experts currently working in research and development, drug development, regulatory affairs, manufacturing, and validation. 

Individuals pursuing this master’s in regulatory science graduate program must have strong science backgrounds, which include an undergraduate or graduate degree in the hard sciences. 

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.  

Careers and Networking

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.  

Why study pharmaceutical regulatory sciences in the RAQA graduate program at Temple?

• Start courses any time of year (fall, spring or summer)
• Enjoy weeknight courses that are offered in an interactive, online format
• Take up to three courses before applying to the MS degree
• Network with professionals across the U.S. and world
• No thesis required; complete 30 credits (10 courses) to earn the degree

Program Format & Curriculum 

Courses are offered online on weeknights during three semesters a year. The program may be pursued on a part-time basis, enabling working professionals to earn a degree while being employed full time. Through careful planning, the degree may be finished within two to three years. 

Required courses for the MS in Pharmaceutical Regulatory Sciences include the following.

• Pharmaceutical Manufacturing I: Preformulation/Formulation (8003) 

• Pharmaceutical Manufacturing II: Solid Dosage Forms (8004) 

• Pharmaceutical Biotechnology (8005) 

• Physical Pharmacy (8006)—offered only in spring of even-numbered years

• Regulatory Sciences: Managing the Guidelines for Quality (5575)

• IND/NDA Submissions (5495)

• Facilities, Utilities and Equipment (5468)

• Chemistry, Manufacturing and Controls (CMC) (5576 or 5577) 

Electives 

One elective in pharmaceutical science and one elective in RA and QA from the following courses. 

Pharmaceutical science electives 

• Pharmaceutical Analysis (8002) 

• Applied Biopharmaceutics (8007) 

RA and QA electives (students must take one) 

• High Purity Water Systems (5478) 

• Cleaning Validation (5516) 

• Computerized System Validation (5498) 

• Vaccines: RA and QA Issues (5572) 

• Biologics/Biosimilars (5515)

• Regulatory Strategy (5606) 

Learn more about the Pharmaceutical Regulatory Sciences MS.

See the curriculum. 

Requirements 

• Thirty credits must be completed, including 24 required and six elective credits from courses listed above. Required courses should complete required courses first, since they provide a foundation of knowledge for subsequent coursework. 

• Students may receive a maximum of six semester hours of transfer credit from other schools, provided the courses are found to be the equivalent of courses offered in Temple’s MS in Pharmaceutical Regulatory Sciences, a grade of B or higher was earned, and courses are no more than five years old. 

• Students will be given five years to complete the degree. No research or thesis is required. 

Program Contacts

Wendy Lebing is the assistant dean of the RA and QA graduate program. 
Phone: 267-468-8560 
Email: qara@nfmy6688.com 

Peter Doukas is the academic coordinator for RA and QA. 
Phone: 215-707-7883 
Email: peter.doukas@nfmy6688.com 

Jean Westbrook is the administrative coordinator for applications. 
Phone: 267-468-8559 
Email: QARA2@nfmy6688.com 

Swati Nagar is the director of graduate studies. 
Phone: 215-707-4948 
Email: phscgrad@nfmy6688.com