Many people have heard of “regulatory affairs,” but do not know what exactly that means. In my understanding, regulatory affairs is a field where you write, review, edit and submit all kinds of documents required in the process of drug development and clinical trials. The ultimate purpose is to gain market approval of your medicinal products (drugs, biologics, medical device and combination products) by the authority agency (FDA in the US) and to remain in good standing post-approval.
Regulatory affairs (RA) professionals are in high demand nowadays. Almost every company producing medicinal products needs RA professionals to help them write documents, interact with FDA and gain market approval of their products. Academic institutions that do clinical research also need RA professionals to write INDs (Investigational New Drug Applications) before investigators can start a clinical trial, and to maintain the INDs during the clinical trial. However, it is difficult to enter the field of regulatory affairs, since most RA positions require prior experience.
Actually, there has been no formal training in regulatory affairs in college in the past few years. People holding RA positions right now came from different backgrounds. Some came from the Research & Development (R&D) department, some did quality control/quality assurance (QC/QA), some were clinical research coordinators (CRCs) or clinical research associates (CRAs). The majority of them had some kind of experience in the pharmaceutical industry or clinical research. All of them should have strong communication skills, both written and verbal.
If you are already in the pharmaceutical industry, congratulations! It’s easier for you to transition into the regulatory affairs field. Try to talk to RA professionals in your company, learn as much as possible from their daily job, and read and understand the related regulations. Networking and constant learning would help you transition.
If you are a student or a postdoc without industry experience, it’s harder for you to break into the field. Fortunately, there are all kinds of training programs in regulatory affairs nowadays. There are online master’s programs or certificate programs in regulatory affairs. Local community colleges or regulatory affairs professional groups may offer this kind of training course or workshop. You only need to attend them part-time at your convenience.
If you are more ambitious, try to obtain a master’s degree, or a regulatory affairs certification (RAC). Those may be a plus in your job search if you have no real work experience. At least they show your strong interest in and the basic knowledge of regulatory affairs. Besides taking classes, you could also attend networking events of local RA professional groups, talk to more RA professionals and try to understand their jobs. If you could find an intern opportunity in regulatory affairs, that would be awesome! Everything you try can help you land an entry-level position in regulatory affairs.
As a PhD candidate in molecular cancer biology, I have been exploring non-academic career options for two years. Now I find regulatory affairs to be the most promising career option for researchers in biomedical science. Besides the solid background in biomedical science, many transferrable skills we gained through our PhD training, including strong logic, communication skills (presentation and writing), multi-tasking and planning ability, would all help us become successful RA professionals. That’s why many RA positions would prefer the candidates to have advanced degrees.
If you are a well-trained biomedical researcher and you are interested in transitioning into the field of regulatory affairs, you just need to get some relevant training and certification, and maybe a little bit of experience. Then the next RA position for you may be around the corner.