Most commonly, scientists move into regulatory affairs as part of a career evolution. As a scientist, you can run into glass ceilings-jobs where no further promotion is likely. In some cases, career progression is blocked by the lack of an advanced degree. In other cases, your scientific specialty is simply not likely to lead to a high level management opportunity. For example, few toxicologists ever become officers of a company unless they leave their own narrow specialty.
Other people find that they prefer dealing with the wider spectrum of information-they find molecular biology too specialized, too out of touch with everyday reality. And for some, finding a science-related job that gets them out of the lab is a strong attraction. It is not uncommon for biologists to develop allergies to the animals they work with, and they are looking for some way to use their knowledge away from the bench. Don't count on a 9 to 5 job, however, particularly if you work for a small and growing company.
One way to move into government is to get a postdoctoral fellowship or the equivalent, working at the FDA, the Centers for Disease Control (CDC), or the EPA. There are various entry-level jobs in the government testing labs that can migrate to the divisions of the government that review marketing applications or perform inspections. Jobs in the FDA are listed on its web site and are also listed in Science or in other scientific journals. People in the military can transfer to the Public Health Service, which staffs various positions within the FDA and the CDC. Carl Peck, a physician in the military who was very interested in pharmacokinetics, went this route and eventually became the Director of the Center for Drug Evaluation and Research at the FDA. This also can be a popular route for people who have had their advance degrees paid for by the government, and who owe the government service time as payback. The National Institutes of Health (NIH) is also a breeding ground for government regulators-to-be, since various clinical trials are conducted by NIH and there is extensive contact between the FDA, CDC and NIH.
In industry, there are also many routes. One common route is to start out in the lab, gathering data and writing reports for submission to a regulatory agency, learning in the process about the regulations affecting your area, then moving over into regulatory when a job opens up. Another route is to find an entry-level position as one of the people responsible for assembling and tracking the mounds of paper that are required to support products, then gradually becoming responsible for more strategic decisions on larger projects.
In companies that have project management groups (usually larger companies), scientists sometimes move over to these groups first, learning the wider scope of product development, before finally ending up in regulatory. In a small company, it can be by a much less logical route-the company needs to have something done, you're bright and available, so you are elected to get it done!
In general, the potential for switching around between jobs and developing titles and responsibilities that reflect your skills are greater in smaller companies, but larger companies provide more jobs and opportunities for getting a toe in the door. Logically enough, even small companies prefer to hire someone with a wealth of previous experience.
You can also start by getting a job for a contract research organization. These companies provide contract services to the pharmaceutical industry, by doing various parts of the product development process such as preclinical testing, analytical work, manufacturing, statistical evaluation, and clinical trials. Many of these companies have entry-level positions available. To find these companies, look on the Internet or look at lists organized by the various regulatory societies. One such list is "Pharmaceutical Contract Support Organizations" issued by the Drug Information Association (DIA). Once you have some training as a scientist who is responsible for generating data that are reviewed by the government, you can move over into regulatory affairs as a veteran who has survived (successfully) regulatory inspections and dealing with the government.
There are many courses and training seminars available where you can learn the regulations. There are courses and seminars offered by societies involved with regulatory affairs, such as the DIA, RAPS (Regulatory Affairs Professionals), and the Food and Drug Law Institute. Each of these groups has a web page that lists upcoming seminars. You can also join these societies and get on their mailing lists-you can even join some of them online.
It is also true; however, that neither course work and seminars nor academic training can provide real-world experience. The diversity of scientific specialties in regulatory affairs reflects the simple fact that this is a career that requires on-the-job training. The best experience is gained through dealing with information that is typically highly confidential to a company; this limits the value of generalized seminars.
It is also important to get to know the people and personalities on the other end of the phone line when dealing with tough issues. No regulations can-or should-be extensive enough to fit all cases. Most decisions are made on the basis of what worked successfully before under reasonably similar situations. The dream product that nicely and tamely fits itself into the published regulations is a rare bird Creativity in interpreting and applying the rules and guidelines is often required when new areas of research begin to give rise to new modalities of therapy, such as gene therapy.
Regulatory affairs professionals occupy jobs at almost all levels within government and industry, from data entry personnel to the commissioner of the FDA. In industry, they rarely become chief executive officer or president, but senior vice presidents or executive vice presidents of regulatory affairs can be found in many companies. As stated earlier, it is not uncommon for people to choose this career simply to avoid glass ceilings. But if your aim is to become a corporate mogul, amassing billions and billions in personal fortune, Regulatory Affairs is probably not the best career choice. Regulatory affairs can, however, become a satisfying and rewarding profession.
One nice aspect true of this profession is that once you have gained a reputation for knowledge and professionalism in your field, you can strike out on your own as a consultant. This is intriguing for entrepreneurial types who like to boldly forge out on their own, marketing themselves and their skills to companies that don't really want to set up permanently the staff needed to bring a product to market. Sometimes consultants are also hired to bring in experience for a type of product that is new to the company, or when the company is looking for help in strategic planning.
The government sometimes brings in consultants to help solve a specific science question. Consultants roam from project to project, and Nancy Chew, a regulatory consultant for many years, has described regulatory consulting as being done best by someone who is easily bored. The nature of the job changes from project to project. It is not, however, for someone who is just starting out in the industry, because having a track record of success is critical in your marketing.
In summary, a career in regulatory affairs can be stimulating and challenging, and it can make extensive use of your scientific training. It requires in-depth knowledge and a tactical view of the regulations and the product, diplomatic skills, and a willingness to dive into details without becoming overwhelmed by them. But most of all, it requires a clear mind that is able to tie together all the scientific disciplines needed to make a product.
