An affair to remember: jobs in pharmaceutical regulatory affairs

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.

Posted: February 21st, 2009 | Author: | Filed under: Education, Regulatory affairs | Tags: , , , , | No Comments »

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