Career Development

Do You Have What It Takes for a Career in Regulatory Affairs?

Regulatory affairs (RA) is a field that offers both plenty of room for advancement, and the opportunity to do important work that makes a real difference in peoples’ lives. Young scientists can enjoy greater job security in regulatory affairs than they might in research and development positions, and it’s not even necessary to have a Ph.D. to enter the field — many regulatory affairs professionals have a bachelor’s or a master’s degree. Once you land an entry-level RA job, it’s easy to move up the ladder.

However, it takes a certain kind of person to succeed in regulatory affairs. Many people, even those in the sciences, have a limited understanding of what the field entails. It can be difficult to break into, and requires a formal education in the sciences, a commitment to ongoing training and career development, strong communication and organization skills, a love of incredibly detailed work, and a passion for helping people.

What Do Regulatory Affairs Professionals Do?

Regulatory affairs professionals are responsible for making sure that companies in the food, drug, biotech, pharmaceuticals, medical device, cosmetics, and natural products industries follow regulatory standards for producing safe products. They’re instrumental in making sure that the prescription drugs, supplements, cosmetics, and medical devices we use are safe and effective. RA professionals may also deal with regulations around clean air and water, to prevent excessive pollution and the health issues that can arise from it.

Sometimes regulatory affairs professionals work for government organizations like the FDA, but they also work for corporate regulatory departments. Many work for pharmaceutical, biotech, and medical device firms. Almost every industry has a place for RA professionals.

Skills You’ll Need for a Career in RA

The work of an RA professional is incredibly detailed. A higher-level RA professional may need to write and review documents that are hundreds of thousands of pages long — long enough that it would take an entire moving van to deliver the document if it weren’t for electronic submissions technology. You’ll need an aptitude for incredibly detailed work, so that you can accurately review the scientific data in these massive documents. If you’re the kind of person who loves details, regulatory affairs may very well be for you.

Strong writing and communication skills are required, as you’ll have to explain the reasoning behind your recommendations to busy senior management officials who may have only a few minutes of time for your advice. Formal education in science or medicine is necessary to understand the research and experimentation that goes into developing new pharmaceuticals, cosmetics, medical devices, or other products, and to ensure that research and development has proceeded according to regulatory requirements. Since much of the work that RA professionals do directly improves peoples’ lives, a passion for helping others won’t go amiss in this industry.

How to Enter the RA Field

Regulatory affairs can be a difficult field to break into, because many companies prefer to hire RA professionals from among their own employees. It’s possible to enter regulatory affairs with a BS, but you can increase your chances of landing a position by getting an MS in regulatory affairs. An online program can be especially helpful if you hope to move into your company’s RA division. If you’ve haven’t yet entered the work force, you can even go so far as to get a Ph.D. and pursue post-doctoral fellowships in the regulatory affairs field, which will prepare you for a higher-level RA role. Some lucky post-doc fellows are offered jobs after they complete their fellowships.

If you’re interested in a career in regulatory affairs, you can start by joining professional organizations like the Regulatory Affairs Professionals Society (RAPS) and the Society of Clinical Research Associates (SOCRA). Involvement in these organizations can help you network with people who can open doors for you in the field. If you work for a company with an RA department, you can gain experience by shadowing some of your company’s existing RA professionals and receiving mentoring from them. Make it known that you’re interested in an RA position. Since many people simply aren’t interested in this detail-oriented work, expressing your interest will go a long way towards helping you land a position in the department.

Though you may have to start at the bottom, advancement is fairly easy for dedicated RA professionals once you have an entry-level position. After a few years of work in the field, you can obtain your Regulatory Affairs Certification (RAC), a credential that proves you understand your country’s regulations and know how to apply them to the industry in which you work. You’ll earn more and have more opportunities with an RAC, but you’ll have to recertify every few years.

The field of regulatory affairs offers career stability and plenty of room for advancement. You’ll get to make a tangible difference by ensuring that the pharmaceuticals, medical devices, cosmetics, foods, and nutritional products that we all use are safe and effective. An alternative to research-based science careers, a career in regulatory affairs lets you stay at the forefront of science without the pressure and unpredictability of an academic or research and development career.

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