The Regulatory Science program at the University of Southern California offers a variety of graduate certificates, a Masters program, and a new Doctorate geared towards regulatory affairs professionals. In the Regulatory Science program, students learn how to guide medical products and foods through the complex regulatory and reimbursement paths required to bring them to market. Regulatory Affairs is an incredibly important part of the drug development process, and in a very real sense plays the key role in determining the success or failure of a drug development program. Ultimately, it’s a company’s regulatory affairs team that must make the case to the FDA that a drug is safe, effective, and deserves to be on the market.
The program has posted a PDF scan of a great article on regulatory affairs careers from The Scientist, which is usually only available by subscription. The article, “For the Hottest Jobs - Go Regulatory”, follows a typical day in the life of a regulatory affairs associate, Joan Kwong, who started her career in the laboratory and made a career switch a few years later. The article offers some great insight on career potential and typical salary ranges.
The article also includes a sidebar piece entitled “So you want to be a regulatory affairs professional - here’s how to get started”. The article notes that one of the hardest things to get used to at first is the abundance of industry-specific jargon and acronyms. A great resource for learning the language of clinical research and regulatory affairs is the online glossary hosted by the Applied Clinical Trials journal. ACT also recently posted an interesting article, “eSubs and eCTD and RPS, Oh My! ” which discusses some of the changes regulatory teams are dealing with as the submission process goes electronic.
Education, Regulatory affairs
career, dayinthelife, glossary, regulatory, Regulatory affairs
Signing up for a formal academic program is one way to put yourself on the fast track to a career in pharmaceutical regulatory affairs.
The Regulatory Affairs Professionals Society (RAPS) is a great clearinghouse of information. If you’re interested in a career in regulatory affairs, it’s a great place to learn more about the role. Membership isn’t cheap ($185), but it is significantly discounted for current students, and includes a subscription to Regulatory Focus magazine, discounts on educational programs, and access to networking opportunities. RAPS offers online courses that may help give you the knowledge you need to land an entry-level role and maintains a list of degree and certificate programs offered at academic institutions worldwide.
Their career information page includes a number of free articles about the regulatory affairs profession. One of them explains what to look for if you’ve decided to sign up for an academic regulatory affairs program.
Regulatory Academic Programs: Deciding to Participate and Selecting a Quality Program (this is a PDF file.)
Here are 10 things the article suggests you look for:
- A diverse curriculum, covering not just drugs but also devices, biologics, and foods and cosmetics.
- A focus on the practical implementation of regulatory issues. Theory is one thing, real-world applications are another.
- High-caliber academic staff with extensive, recent, real-world experience in regulatory affairs.
- Instructional variety, incorporating not just lectures but case studies, multimedia, mock audits and team projects
- Networking opportunities — a chance to learn and develop connections with your fellow students and instructors.
- Convenience. Many programs can be completed part-time. Online courses can let you learn from home.
- Flexibility.
- Supportive administrative staff.
- Affordability.
- Reputation. A certificate from “Joe’s Auto Lube and Reg Affairs Academy” won’t have the same value as successful completion of a program that’s known and respected by the industry.
Industry associations, Regulatory affairs, Training
Education, industry association, RAPS, regulatory, Regulatory affairs
