Overview

Master of Science in Pharmacy, BioPharma Regulatory Affairs

The rapid expansion of pharmaceutical and biomedical products requires a greater number of highly skilled Regulatory Affairs professionals to oversee the approval for new product lines and manage compliance with complex regulatory policies and procedures. Specialized and convenient education is crucial for busy professionals to develop and sustain an understanding of the ever-changing regulatory environment. The Master of Science in Regulatory Affairs assures the strong professional background you need to succeed in the regulatory industry.

Regulatory affairs professionals are multi-disciplinary with diverse backgrounds and UGA offers the only regulatory program in the US that covers requirements in both the medical and veterinary industry. With the choice of either a thesis or non-thesis path to degree, this program is ideal for individuals with a clear objective to cultivate a career in regulatory affairs and those with an industry background desiring advanced education in regulatory management.

Offered through the College of Pharmacy, the curriculum covers requirements for pharmaceutical, biologic, medical device, animal health, international regulations, and combination products. Regulatory Affairs professionals are employed in industry, government, and academia and provide a range of services related to the regulation, development, manufacturing and marketing of pharmaceuticals, medical devices, in vitro diagnostics, biologics, biotechnology, nutritional products, cosmetics, and veterinary products.

Additional information for current BioPharma Regulatory Affairs students can be found at rx.uga.edu.

Accreditations

The University of Georgia is accredited by the Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) to award baccalaureate, masters, specialist, and doctoral degrees. Contact the Commission on Colleges at 1866 Southern Lane, Decatur, Georgia 30033-4097, or call 404-679-4500 for questions about the accreditation of the University of Georgia.

College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE).

Technology Requirements

  • Computer with current operating system (Windows or Mac). Additional peripherals such as webcam, headphones and printer may be required.
  • High Speed Internet Access.

Cost

Tuition & Fees

Online Tuition $729 per credit hour 38 credit hours (estimate) $27,702 USD
Student Fees $597 per semester 6 semesters (estimate) $3,582 USD
Total Program Cost     (estimate) $31,284 USD

Tuition and fees are subject to change. Current tuition and fees are available on the Bursar's Office website. If you register for less than 5 credit hours, student fees are reduced to $366 in that semester. 

Online students pay the following fees: Connect UGA, Green, Special Institutional, and Technology. See UGA Tuition and Fees for the complete schedule of fees.

Other Costs

Additional costs may include:

  • Textbooks
  • Exam proctoring fees
  • Technology upgrades 

Financial Aid

Visit the Office of Student Financial Aid for information about financial assistance.

Corporate Assistance

Consult your employer about the availability of tuition reimbursement or tuition assistance programs.

Military Assistance

Active duty military, veterans, and military families should visit Veterans Educational Benefits to take full advantage of available financial assistance and educational benefits.

University System of Georgia Tuition Assistance Program (TAP)

The purpose of TAP is to foster the professional growth and development of eligible employees. For more information, see Tuition Assistance (refer to the Distance Learning section). 

Admissions

Credit and Transfer

Total Hours Required to Earn Degree:  38 - 39 (credit hours)

Maximum Hours Transferable into Program:  6

A maximum of 6 credits may be transferred into the program with Director's approval. The Pharmaceutical and Biomedical Regulatory Affairs Graduate Education Program is a member of the Atlanta Regional Council for Higher Education (ARCHE), which allows students to register for approved courses at an approved ARCHE member institution.

Admission Requirements

Students applying to The University of Georgia must be accepted by the Graduate School. Persons holding a bachelor's degree from any institution accredited by the proper regional accrediting association are eligible to apply for admission to the Graduate School. Preference will be given to applicants with a degree in sciences, healthcare, or engineering.  Preference will also be given to applicants employed in the pharmaceutical, medical device, biotechnology industries or related field.

A combined (verbal and quantitative) GRE score of 1000 or higher is preferred. However, GRE scores are assessed in relation to other factors such as GPA, background, and interview for determination of admission and we welcome applications of all qualified persons with a sincere interest in Pharmaceutical and Biomedical Regulatory Affairs. The Regulatory Affairs Program offers a Graduate Records Examination (GRE) Waiver Request option.  No waiver request is guaranteed and we encourage our applicants to consider taking the GRE as part of the application process. The GRE is one of the benchmarks we evaluate to ensure that an applicant can make it through the rigors of the UGA Regulatory Affairs Program.  Yet, for those applicants with significant work experience or other graduate education experience, the department may consider waiving the GRE requirement.

Application Checklist

  1. UGA Graduate School Application – Submit the Graduate School application online.
  2. M.S. Regulatory Affairs Application – Complete the pdf application and mail to:

Regulatory Affairs Graduate Education Program
The University of Georgia Gwinnett Campus
2530 Sever Road
Lawrenceville, Georgia 30043-4005

  1. Test Scores – Send recent official entrance test scores (less than five years old) to the graduate school. UGA institutional code for ETS reporting: 5813  
    1. GRE
    2. International applicants must also submit TOEFL or IELTS scores.
  2. Statement of Purpose – Send to the department graduate coordinator. A statement of purpose should clarify the candidate’s relevant background, interests, and goals.
  3. Letters of Recommendation – Submit three letters of recommendation online to the graduate school. Letters should be from individuals who can evaluate the applicant’s scholarly ability and potential for success in a graduate program. Preferably at least two of them are from faculty who have instructed the applicant in a previous program of study.
  4. Résumé or curriculum vita – Send to the department graduate coordinator.
  5. Official Transcripts – Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission.
  6. Interview with Department - Schedule your interview with the department and ensure that it is complete prior to the application deadline.

Application Deadlines

Fall:  June 1

Spring: November 1

International Applicants

Fall:  April 15

Spring: October 15

Curriculum

Program Structure

This masters program is a part-time only program and operates on a traditional academic calendar. The first day of class is generally a live session at the UGA Gwinett Campus.  All students are expected to attend the Program Orientation. 

Students may chose either the non-thesis or thesis path to degree completion. 

Non-thesis Path 

The non‐thesis pathway will engage you in real‐world application, practice, development, and experiential learning needed for career success. These practical aspects of the job are highly desired by employers and the non‐thesis pathway is particularly suitable for students who do not plan to pursue research intensive positions or complete a Ph.D.

This path requires a minimum of 39 semester hours and includes an applied project or internship and a comprehensive examination.

Thesis Path 

Completing a master's thesis demonstrates research competencies, involves direct research experience, and strengthens ones potential application to Ph.D. programs. A thesis may be especially valuable for work requiring research in cutting‐edge development companies.

This path requires a minimum of 38 semester hours and includes the development and oral defense of a research-based thesis. 

Courses

Sample Part-time Schedule for a Single Academic Term

  Fall Term Spring Term Summer Term

Sample Year (part-time schedule)

  • PHAR 6100: Quality Assurance & Quality Control
  • PHAR 6200: Clinical Trials & Monitoring
  • PHAR 6800: Applied Project
  • PHAR 6130: FDA Submissions
  • PHAR 7100: Biostatistics
  • PHAR 6210: Project Management for Clinical Trials

MS in Regulatory Affairs Program Plan

Core (22 semester hours)

Completion of Certificate Courses (14 semester hours)
PHAR 6010 Pharmaceutical, Biotechnology, and Device Industries (4 sem hrs)
PHAR 6030 Current Good Manufacturing Practices (4 sem hrs)
PHRM 7230 Ethical Issues in Research (3 sem hrs)

Additional Core Courses (9 semester hours)

PHAR 6100 Quality Control and Quality Assurance (3 sem hrs)
PHAR 6120 Process Control and Validation (3 sem hrs)
BIOS 7100 Biostatistical Applications for Pharmaceutical & Biotech Industries (3 sem hrs)

Advanced Electives (minimum of 6 semester hours)

Research Regulatory Affairs
Quality Control and Quality Assurance
Internship in Regulatory Affairs (3 sem hrs)
Clinical Trials Design & Monitoring
Clinical Trials Project Management (3 sem hrs)
Developing Leadership Skills
Drug Development
Veterinary Products

Thesis Track (6 semester hours)

The master's thesis is either a basic or applied research project conducted by the student and supervised by the student's advisory committee. A final oral examination is required.
PHRM 7000 Masters Research (3 sem hrs)
PHRM 7300 Masters Thesis (3 sem hrs)

Non-thesis Track (9 semester hours)

Students pursuing the non‐thesis track must complete and receive committee approval of a focused area of study/exploration and pass a comprehensive written examination, administered by the student’s graduate advisory committee.
Additional elective(s) or other appropriate courses related to the student’s career objective (3 sem hrs).
Applied project and/or internship related to the student’s career objective (3 hrs)
PHAR 6800 Applied Project in Regulatory Affairs&n
AND/OR
PHAR 6900 Internship in Biomedical Regulatory Affairs
Masters Seminar in Regulatory Affairs (3 sem hrs)

News & Events

UGA Online Regulatory Affairs Alumni Commit to Saving Lives by Learning the Latest in Medical Device Regulations

Regulation of medical devices is a crucial aspect of the healthcare field that many of us depend on in our everyday lives. Online Regulatory Affairs faculty and students are committed to saving the lives of others by improving and ensuring the quality of medical devices. Learning from industry professionals about the future direction of regulations is a critical component. UGA recently wrapped up its 4th annual Medical Device Regulations conference, where those in the pharmaceutical and biomedical industries were able to hear from industry professionals about the quality and production of medical devices.

UGA Nationally Reaffirmed as a Top Military School

Once again, the University of Georgia has been nationally reaffirmed in 2016 as Military Friendly, Best for Vets and a Top Military College/University. Since the establishment of the Student Veterans Resource Center (SVRC) in the spring of 2013, UGA has made significant progress in connecting student veterans to one another, as well as to campus and community resources. UGA continues to maintain active affiliation with both the Student Veterans of America and the Got Your Six campaign, where faculty and staff attend a training session to become certified as veteran-friendly.

Strategies for Successful Graduate Students

Years spent in graduate school are undoubtedly a stressful and anxiety provoking period in a person's life. There are academic pressures, family pressures, career pressures and the pressure to balance it all.

Order Items Online, Come To Graduation In Person!

As we all know, graduation is coming up, and spring and summer graduates are gearing up for this special day. At UGA Online, we are of the firm opinion that our online students should have the same graduation experience as in-person students.

Alumna Profile: Kelly Winn's BioPharma Degree Was Along Her Natural Career Path

Kelly Winn recently graduated from the online M.S. in Pharmacy, BioPharma Regulatory Affairs program in December 2015, and has used her degree to propel herself along her natural career path where she works at the Georgia Institute of Technology. She started the degree up in January of 2014 with the intention of evolving her role as a regulatory compliance administrator into developing the first Regulatory Affairs program at Georgia Tech. 

UGA faculty learn to apply the Quality Matters rubric to online courses

Over 30 of the University of Georgia's faculty and staff who teach online courses participated in a Quality Matters workshop last semester offered through UGA's Office of Online Learning. Quality Matters is a faculty-centered, peer review process intended to promote the design and development of quality online courses, and the Applying the Quality Matters Rubric workshop introduces course designers to these standards. 

Guest Blog: Online Video Tutorials for Distance Education Students

By: Lynn Cahoon
Distance Learning Librarian

The library research resources available to distance learners and faculty have never been better. No matter what your topic or where you are studying, the books and articles you need are only a few clicks away. But to find them, you’ll have to learn to use the GIL online catalog and GALILEO databases, which can seem intimidating to the uninitiated. 

Graduation Fair: Ordering Graduation Items Virtually

The University of Georgia Bookstore is hosting a graduation fair until March 3 to kick off cap and gown sales for all candidates for spring graduation. Students can purchase announcements, graduation portraits, diploma frames and alumni merchandise.

UGA Online Education Now Available to All 50 States

The University of Georgia is pleased to announce participation in SARA, the National Council for State Authorization Reciprocity Agreements. UGA’s participation in SARA positions the university to offer distance education to residents across all 50 US States.  Before SARA, UGA was able to offer online education to only 36 US states in addition to international students.

Engaging in Sustainable Online Course Development

The instructional design team at the Office of Online Learning takes pride in working with faculty to create online learning experiences that live up to the academic standards of the University of Georgia. We also consider how the environment we work in can support the continued offering of the courses we help develop. To this end, we encourage faculty to engage in sustainable course development practices for all online courses.

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Contact Information

Contact the online Regulatory Affairs Coordinator for answers to any additional questions you may have. 

Email us using the request for information form

or call

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