Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy
Five Ways a Graduate Degree Advances Your Regulatory Career
Regulatory requirements for training are stated in the first line of the U.S. Code of Federal Regulations, Title 21, Volume 8: "Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed."
The need to demonstrate sufficient training and education spans preclinical, clinical, manufacturing, and post marketing operations in the pharmaceutical and related industries worldwide.
By pursuing an advanced degree, you are helping your company fulfill these regulatory requirements.
Many companies encourage employees to pursue advanced education by providing tuition remission. Taking advantage of this generous benefit advances an employee's knowledge and career while providing lifetime credentials.
Even if you already have an advanced degree in the physical sciences, business, engineering, computer services, or other field, an additional degree in Regulatory Affairs will add important credentials to your resume, attesting to your knowledge of the field.
One of the best ways to distinguish yourself in a highly competitive job market is to pursue as much education as possible.
Earning a graduate degree from a reputable program in Regulatory Affairs not only provides in-depth knowledge about regulations, clinical practices, compliance, global agencies and current regulatory issues, but also develops your ability to analyze arguments, interpret data, and make key decisions at work.
Graduate courses prepare you for a leadership role by teaching you how to read critically, organize your thoughts cogently, and expand your knowledge of the latest trends in a particular discipline. By reading extensively, you'll foster your writing skills, which will serve you well throughout your career.
A graduate program also challenges you by requiring presentations and public speaking: invaluable tools when you engage in company meetings or participate in formal sessions with regulatory agencies.
Graduate study provides an opportunity to expand your mind and to take courses that develop your talents and interests. Pursuing courses in topics outside your immediate realm of knowledge (whether the field is pharmacovigilance, validation, global regulation, quality systems management, or biosimilars) helps you expand the skill sets on your resume, providing you greater flexibility when you pursue career opportunities.
Many of the top Regulatory Affairs graduate programs allow students to pursue specialized certificates in areas such as biotechnology, medical devices, clinical trials, and so forth, providing you with well-recognized credentials in key areas of the industry.
When you enter a graduate program, you demonstrate to your supervisor and company your willingness to sacrifice personal time to earn academic credentials. Pursuing a master's degree is a long-term goal, taking anywhere from one to five years or more to achieve.
Signing up for the first course shows motivation and courage, but making it through an entire degree program clearly illustrates your commitment and drive: you follow through on goals and don't quit in the middle.
By starting a master's degree in Regulatory Affairs, you are giving a clear signal that you are serious about advancing in the industry, since you're spending the time to become a "master" in the language, trends, and future direction of the industry.
When you decide to start your graduate courses, it can help to make an appointment with your supervisor to discuss your decision to return to school. You can explore areas in Regulatory Affairs or Quality Assurance which your supervisor feels you need to develop to be more effective in your current position.
By setting aside formal time to chat, you create quality time with your supervisor and reinforce your serious intention to advance in the industry. You are showing employers that this is an important decision that will require support from the people around you, both family and supervisors. By including them in a conversation, you gain their respect and help in making that goal come true.
A graduate degree requires a commitment of time, effort, and money, which is why it is crucial to earn your degree from an accredited school.
Not sure what "accredited" means? An accredited university or college periodically undergoes a review process by an external agency. This extensive process examines an institution's academic programs, faculty, research, technology, library holdings, and student services. The review takes weeks or months to complete and either gives a school a "thumbs up" or requires the school to make changes before accreditation is approved.
Earning your degree from an accredited school means that the institution has undergone this rigorous review process, so you know the degree you receive will be well respected. If you're not sure whether the school you're interested in attending is accredited, ask them for the name of the accrediting agency.
You should also investigate the reputation and credentials of the graduate program you'll be attending. RAPS and LinkedIn are excellent resources for identifying successful industry leaders and seeing the importance that advanced education in Regulatory Affairs has played for many of them.
The instructors in Regulatory Affairs graduate programs are experts in their disciplines: corporate counsels with first-hand experience in industry law cases; vice-presidents of regulatory departments with extensive experience overseeing INDs and NDAs; biostatisticians and pharmacoepidemiologists who analyze safety data daily; directors of regulatory intelligence who monitor trends daily on global regulatory websites, senior directors of regulatory advertising and promotions policy who work with pertinent regulations on a daily basis; officials from key regulatory agencies, including the FDA.
When a program offers a multitude of instructors, you benefit from their vast range of experiences and insights. You also gain first-hand knowledge of today's regulations and issues, which provide invaluable insights in doing your current job.
Well-established programs draw students who enroll in courses for the same reasons you did: they are passionate about their career path in Regulatory Affairs and want to learn everything they can. The students who take classes with you may become resources as your career progresses, forming a network of tomorrow's leaders.
Don't miss the opportunity to meet as many students, instructors, guest lecturers, and regulatory personnel as possible during your academic program. You will be amazed at how many of them you may continue to encounter in your industry career.
Written by: Wendy Lebing, MALD, MS
Assistant Dean and Director of International Programs
All Rights Reserved. This article may not be reproduced or copied without written permission from Wendy Lebing or the Quality Assurance/Regulatory Affairs Graduate Program of the Temple University School of Pharmacy.
About the RA and QA Graduate Program at Temple University
Phone: 267.468.8560 Email: QARA@temple.edu
The first university to develop a graduate program in Regulatory Affairs and Quality Assurance, Temple University School of Pharmacy (TUSP) continues to set the gold standard in this dynamic professional discipline.
Since 1968, TUSP has remained in the forefront of industry education, offering more courses in Quality Assurance, Regulatory Affairs, and related disciplines (medical devices, biologics, validation, clinical trials, etc.) than any other similar graduate program.
We offer the most comprehensive curriculum in RA and QA:
Online Master's of Science Degree in Quality Assurance and Regulatory Affairs;
Online Certificates in Drug Development, Clinical Trials, Medical Devices, Global Pharmacovigilance, Biopharmaceuticals, Biologics, and Post Master's Certificate.
Our courses expose students to real-world developments in the pharmaceutical and related industries, from current quality practices to the latest trends in domestic and global regulation. Our students gain a deep appreciation of the complexity of blending pharmaceutical and regulatory science on a global scale.
Our master's degree in Regulatory Affairs and Quality Assurance is online. We also offer courses in a traditional classroom setting and videoconference directly to pharmaceutical companies.
Students may earn certificates online and apply all of the credits towards the MS in Regulatory Affairs and Quality Assurance.
Join the more than 1700 graduates from our Master of Science in Regulatory Affairs and Quality Assurance, who continue to be leaders in the industry.
Quality Assurance / Regulatory Affairs Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
© 2008, Temple University School of Pharmacy. All rights reserved.