Regulatory affairs is one of the hottest and fasting growing career tracks in the pharmaceutical, biotechnology and medical devices industries. The trouble is,there is very little formal training available to prepare individuals for careers in regulatory affairs. Historically, most regulatory affairs professionals honed their skills through on-the-job training. This meant that the only way to pursue a career in regulatory affairs was to first get hired at a pharmaceutical or biotechnology company and then transfer into the regulatory affairs department to learn your craft. Not surprisingly, due to expansive growth of the biotech and medical devices industries, there are ongoing shortages of regulatory affairs professionals, most notably in the area of regulatory writing. In an attempt to deal with these shortages, a number of universities including Georgetown University and SUNY-Stonybrook offer some regulatory affairs training as part of their
master’s degree and certificate programs in biotechnology. Further, the Regulatory Affairs Professional Society (RAPS) recently developed several certification programs and an online university that offers four (4) introductory regulatory affairs courses to interested individuals.
For those of you graduate students and post-doctoral fellows who enjoy writing, are not bored by clinical research and like to work on computers most of the day, a career in regulatory affairs may be right for you!
Until next time….
Good Luck and Good Job Hunting!!!!!!!!!!!