Regulatory affairs is a booming career field.
The importance of the regulatory affairs profession comes from the fact that 25 cents of every dollar American consumers spend pays for a product or service regulated by the FDA, the US Food and Drug Administration. All the food, beverages, cosmetics, and nutritional supplements you buy undergo rigorous regulation to ensure their safety and efficacy before they can hit the shelves of your local supermarket or pharmacy.
The FDA doesn’t just regulate consumer goods. It also regulates medical technology, including medical devices, monitors, and biotechnology to ensure they are safe, effective, and perform as expected. And as the pace of medical innovation speeds up, the need for regulation only increases.
Some regulatory affairs officers help companies meet FDA requirements so they can compete in the American marketplace. Other regulatory affairs officers work for the FDA in keeping the American public safe. In the pharmaceutical and medical devices industry, regulatory affairs officers are involved at every point in the product life cycle, from research and development through clinical testing, FDA approval, manufacturing, marketing, distribution, and post-market surveillance.
The Bureau of Labor Statistics identifies regulatory affairs officer as an up-and-coming profession, with 698,330 new jobs filled by 2029. Regulatory affairs manager jobs pay from $56,330 to $197,270, with an average annual salary of $123,980.
So, how can you get a regulatory affairs job? Let Fladger Associates walk you through the process, an industry leader in pharmaceutical careers.
- Decide whether regulatory affairs is right for you
Not everyone is happy working as a regulatory affairs officer. This job can involve tight deadlines, anxious colleagues, and public accountability for actions that have an impact on the survival of the company. It requires careful attention to factual detail and the ability to deal with a tremendous volume of information.
If you enjoy having a highly responsible position and the pay that comes with it, then being a regulatory affairs officer may be for you. But if you prefer a more creative, artistic approach to your work, you will probably be happier in another profession.
- Practice your soft skills
All regulatory affairs managers need critical thinking skills. They need to be able to deal with competing priorities and to be able to exercise discretion about the times and places in which they reveal facts.
All regulatory affairs managers need excellent English language skills (and excellent skills in other languages if their companies sell products outside the United States). The ability to state unequivocal findings is essential for satisfying the FDA and state regulatory agencies.
All regulatory affairs officers need people skills. They need the ability to negotiate and to lead projects. They need to be able to develop relationships of trust and confidence across different departments.
Regulatory affairs officers benefit from a global perspective. Even if their companies do not sell their products outside the United States, they need to understand global competition and opportunities for global cooperation.
Even liberal arts majors can develop critical thinking, communications skills, and a global perspective. It is important not to limit coursework to the liberal arts, however, to be prepared to take on technical challenges.
- Develop a depth of expertise in a line of products
You don’t have to have a master’s degree in a science field or in regulatory affairs to get a job as a regulatory affairs office, but it helps.
Because a tremendous range of businesses are regulated by the FDA, there is no single path to getting a regulatory affairs job. Regulatory affairs officers are expected to have in-depth knowledge of their products and the regulatory climate for their industry, but they can specialize in a particular kind of product.
Regulatory affairs officers in the medical device industry, for example, typically need to have a basic knowledge of biochemistry, pharmacology, statistics, and research design. They need to understand how clinical trials are conducted, including the ethics of clinical research. They need to know how to present the results of clinical research to the FDA and CDC before their products ever reach their market. Then they need to understand their company’s manufacturing processes and post-market surveillance techniques to make sure they can continue to sell it.
A regulatory affairs officer in the food products industry, contrastingly, needs a different set of skills. The FDA has already decided that every item on a very long list of foods and food product ingredients is safe, so the company only has to stick to that list. The inputs into the food production process, however, require constant monitoring. The regulatory affairs officer for a food company needs to have an in-depth understanding of how their products are manufactured. The regulatory affairs officer of a food company needs to understand every aspect of safety assurance. And the regulatory affairs officer of a food company needs crisis management skills when a mishap in the supply chain or at the manufacturing plant or during distributions leads to a recall.
In the pharmaceutical, medical devices, and medical technology fields, it is almost impossible to acquire the depth of knowledge required to be a regulatory affairs officer without a university degree in an appropriate field. In some other industries, it may be possible to gain needed knowledge through on-the-job experience. But all regulatory affairs officers need detailed knowledge of the products their companies make.
You can gain those skills in the classroom or on the job at a company that makes the kinds of products for which you want to be a regulatory affairs officer.
- Get certified as a regulatory affairs officer
Take the exams for membership in the American Society for Quality. Get your certifications from the Regulatory Affairs Professionals Society. Become a Certified Clinical Research Professional. Earn the credentials that your industry respects.
Fladger Associates matches regulatory affairs professionals to jobs where they can excel.
