Clearly, entomologists are more likely to find work in the Environmental Protection Agency (EPA) or with a pesticide company than in a company that makes heart valves, and protein chemists are more likely to find a job in a biotech company or with the FDA than in a company that manufactures parenteral nutrient solutions. And while an advanced degree is less important in regulatory affairs than it is in academia or in basic research in industry, veterinarians are more likely to be put in charge of running large field trials of a new antibiotic for cattle than is someone with a bachelor's degree, and senior management positions are more typically filled by people with advanced degrees. Exceptions to these rules abound, of course, because demonstrated ability to get the job done is extremely important in this field.
So how do you know whether this would be a good career choice for you? The first thing you need to know is which regulations govern your product area. In addition, most people find that good people skills are important, and organizational skills and the ability to store and track information are usually critical.
An ability to see the broad view without getting lost in the details is another important skill, particularly for people aiming for more senior level management positions. A thick skin can also be an asset, particularly when acting as the bearer of bad news to top management. ("Yes, the FDA really will require us to do another $20 million clinical trial. No, the FDA won't let us claim our product cures everything in our labeling, unless we prove it.")
Flexibility, the ability to change directions quickly as new information comes in, and the willingness to give up cherished plans and theories are all strong assets in this career. You may think that you know what patient group will respond best to a new drug, only to find out as the trials proceed that the drug doesn't work at all well with those patients-but it does work spectacularly well in another disease. You may find yourself having to deal with last-minute manufacturing changes, trying to decide what else is going to change as a result. The regulations can change, meaning that a submission that was almost ready to go out the door suddenly needs to be reorganized, or extra studies must be done. Or, the company submitting the drug comes up with new and inexplicable results (good or bad) with implications that have to be determined quickly: do we stop ongoing clinical trials? Do we change trial design?
People skills are very useful in this kind of job. Product development- whether of a device, a drug or a pesticide-requires the combined input of whole teams of specialties. As a regulatory affairs professional, it is your job to gather information from across groups, and to help make sure that the story you are trying to sell to the government (or to industry) is complete and consistent. In some cases, this may mean coaxing a report in the appropriate format out of an unwilling investigator, or negotiating product specifications that meet manufacturing realities, clinical necessities, and legal requirements. You can find yourself in a hostile situation when different groups within your company or agency are fighting turf wars, but you are responsible as liaison to the outside world for making all seem calm and untroubled. You could also be the one who helps to get new laws passed to protect consumers, acting for your consumer group in a position where your ability to get the job done depends primarily on your powers of persuasion.
The ability to hear accurately not only what people are saying, but also what they are not saying, can be crucial. In working for the government, you may find yourself in a position where, because of your experience with similar products, you expect that a product may have effects clearly unanticipated by the manufacturer. In this case, you must get the company to do the necessary evaluations-but you may not be able to tell them why, because it would give them confidential information about a potentially competing product in development. As the parallel professional in industry, these hints can be essential to getting your product to the market quickly, and you need to know when to push for more information, and when to quit while you are ahead.
Organizational skills are very important as well. The typical NDA can be 200 volumes of more than 250 pages each, reflecting data acquired over 10 or more years of research. Organizing that information as it comes in, sorting it, storing it, and assembling it is a monumental job, requiring whole teams of people working for months. On the government end, reading and absorbing the information, quickly finding key questions, and coordinating the overall response to the company in the short timetable dictated under the new User's Fees rules can be tough. But when you realize that most companies are working against management goals of "X number of NDA's filed per year," you can imagine that the Christmas rush has a whole new meaning to the receiving docks in Washington. Keeping track of the various documents you are supposed to review, of what company responded to which query (and which issues are still outstanding), and preparing thoughtful written reviews of each application on time puts demands on anyone's filing system.
More and more, a talent for strategic planning is becoming essential as regulatory professionals are asked to assist in overall product development planning. Taking into account existing and in-process regulations and guidelines can help determine the probable development times and risks for a new product. The ability to successfully predict the quickest and most likely pathways to the marketing of a product has been known to make or break a young startup company that has only limited financial resources available to stay alive long enough to get a product to market.
Being in regulatory affairs has its downsides, too, as with any other job. An additional useful job skill is to be able to deal with the sequelae of being the bearer of bad tidings. Because regulatory professionals are the interface with the government, for some people within a company, they are viewed almost as being part of the government. Regulations passed to prevent problems caused by other companies sometimes seem to become the fault of the regulatory affairs group. Similarly, reports of compliance problems spotted by the company's own regulatory group can be greeted with ingratitude. The regulatory group frequently shares the blame when the government refuses to permit the marketing of a new product.
Never forget that over the years, you develop a reputation within your area. If you have the reputation for straight shooting and fair evaluation based on good science and backed by the facts, you are more likely to get things done in your own organization as well as with the companies or government agencies with which you deal.
