Careers in Regulatory Affairs: A Sure Bet!

Posted in BioJobBuzz

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!!!!!!!!!!!

  • Chantay Williams

    Great article! Which companies should I apply to if I am interested in regulatory affairs, but have no experience? Also, what can I do to become more familiar with the industry? I have a Master’s degree in Public Health and a Master’s degree in Business Administration. How difficult would if be for me to transition to regulatory affairs?

  • peter castellano

    I’m an attorney with almost 5 years of experience in compliance and regulatory affairs, but in a different industry, not in the science world. anyone have any advice on making the transition? i find the science and medical field much more interesting than what I’m doing now, but not sure how to make the move.

  • Jonathan Hart-Smith

    Hi there
    There is a lot in what you say. I run a recruitment company specialising in recruiting for Regulatory Affairs staff in the UK and can often help people find that first step on the ladder. My advice is to contact a GOOD recruitment company that specialises in this area and they will help you find a suitable role to get some experience and start your career.
    Good luck

  • Milisa

    Hello all! I actually found and applied to a Masters program for Regulatory Affairs in Biologics, Pharmaceuticals and Medical Devices. I have a background in medical, legal, compliance and a BS in International Business. To be able to incorporate all that I love into one is a dream come true! Northeastern University in Boston, Massachusetts (USA) offers the program both online (distance education) and in the traditional classroom. Best of luck to all of you! Milisa

  • Stephanie

    Excellent Regulatory Affairs Opportunity!!!
    Our client is a mid-sized global, specialty pharmaceutical company based in New Jersey and they seek to fill a senior-level position with a regulatory affairs professional knowledgeable of the best practices of global pharmaceutical regulatory submissions. This position will be
    responsible for the management, direction, performance and
    accountability of the local Regulatory Affairs staff based in North and South America and must ensure that currently marketed and potential new products meet the regulatory requirements of the United States, Canada and Latin and South American authorities. Compensation will approach
    Please Contact Stephanie C. at (610)941-0700 ext.2 or

  • Vanita Krishnan

    Hello All!
    I am a dentist from India and I am currently enrolled in a research based Master’s Program at McGill University, Canada.I am, however, extremely keen about pursuing a career int he field of Regulatory affairs in medical devices industry.I am looking out for internships too for summer 2012.Can anyone suggest ways to get an internship for over 12 weeks in this field in and around Montreal?