Mention a career in regulatory affairs, and most young scientists will not know what you are talking about. The lack of awareness arises because, aside from a small collection of advanced educational programs in regulatory affairs, science curricula are not designed with this profession in mind. Yet regulatory affairs can provide a rich and rewarding career path for scientists.
The Regulatory Affairs Professionals Society describes this field as "vital to making safe and effective health care products available worldwide," but this indistinct description fails to capture the true character of this satisfying occupation. Although regulatory affairs careers are diverse, the career paths and views of the two regulatory professionals described below will help illuminate the nature of regulatory affairs careers.
Stella Jones started her career in synthetic organic chemistry. After completing her graduate degree at Johns Hopkins University in Baltimore, Maryland, Jones was hired as a senior research scientist at the research and development (R&D) unit of Smith Kline & French Laboratories (now GlaxoSmithKline). After a few years, she realized that "basic research was too narrow a scope within the pharmaceutical R&D arena" for her interests. With the help of her supervisor, whom she describes as a great mentor, Jones mapped out alternative career options within her area of expertise. By following her expanding interests, she navigated through the pharmaceutical R&D sector until she reached her current position as head of regulatory affairs at the biotech company Centocor.
Like Jones, Janet Woodcock also started out in chemistry. After working briefly as a B.S.-level analytical chemist, Woodcock returned to school to get her M.D., specializing in rheumatology. She then went to work at the University of California, San Francisco, Medical Center. The course of Woodcock's professional life was subsequently altered by a move to Washington, D.C. She arrived in D.C. with a new family, looking for a flexible job. The U.S. Food and Drug Administration ( FDA) turned out to be the family-friendly employer she was looking for, so she started as a part-time reviewer in the biologics department. Over her time at FDA, Woodcock has moved up, first by running the review group for biologics, then becoming the deputy director of biologics, then head of the Office of Therapeutics, and finally being appointed head of the Center for Drug Evaluation and Research ( CDER), a division of FDA committed to ensuring that "all prescription and over-the-counter drugs are safe and effective."
Although they work on different sides of the regulatory divide, Jones and Woodcock have similar views about their careers in regulatory affairs. They both emphatically agree that formal training in science is essential for regulatory work. Jones's staff of 110 people is currently composed solely of trained scientists with B.S., M.S., or Ph.D. degrees, but she also feels that physicians are well suited to the regulatory field. Woodcock manages 2200 physicians and scientists, many of whom have advanced degrees and specialized training. However, she also notes that there are positions in CDER for scientists with other backgrounds.
In addition, these two scientists agree that knowledge of the regulatory process, laws, and policies generally does not require formal training. Both Jones and Woodcock entered the area of regulatory affairs from pure science backgrounds and attribute their extensive knowledge in those other fields to years of on-the-job training as they worked at different levels of their respective companies. Jones says, "I took a systematic approach by taking positions in my career in departments such as clinical R&D and project and portfolio management, so that I could maximize the opportunity to gain in-depth knowledge of every step of the R&D process." Those past experiences have been essential for the regulatory position she now holds.
It is the continued learning process to keep current with the latest scientific and regulatory developments that both Jones and Woodcock appreciate most about their jobs. In order to excel in regulatory affairs, it is necessary to be knowledgeable about the latest scientific developments and discoveries, as well as about current regulatory laws and policies. Although maintaining a high level of expertise in so many areas may be exceptionally demanding, that is exactly what these scientists enjoy. Says Woodcock, "Given [my] personality, [I] thrive on the endless array of challenges and variety that [my] job provides." She also enjoys staying at the forefront of scientific development without doing bench research. Jones concurs: "The most interesting aspects of my position center on the opportunity to constantly gain new scientific, medical, and policy knowledge. ... Learning is not only great fun; it is also most satisfying from professional and personal standpoints."
Woodcock welcomes the diversity of skills her job requires. Within a given week, she will perform activities such as drafting educational pamphlets for the general public and appearing before Congress. In all of her daily endeavors, Woodcock considers communication and organizational skills to be paramount. Jones also relies on these skills in managing her staff and directing the scope of regulatory strategies of Centocor. Communication is crucial in regulatory affairs, as there must be a clear and open dialog between lawmakers, the regulated companies, and consumers, for whom the entire process was designed.
According to Jones, moving in and out of regulatory affairs is relatively easy. The scientific knowledge and skills needed in regulatory affairs, she explains, are similar to those needed in other scientific jobs. Jones has recruited scientists from many different backgrounds, including chemical development, clinical R&D, preclinical/toxicology, and information management. Woodcock, who does not believe in being stationary for too long, plans to take advantage of this flexibility in the future and transition away from regulatory affairs to be closer to the heart of the science.
One opinion shared by Jones and Woodcock is that of all their responsibilities, they like the budget process least. However, that seems to be a common attitude held by professionals, especially scientists.
Jones and Woodcock have both achieved highly successful and satisfying careers in regulatory affairs. They agree that scientific training, communication skills, and the desire and drive to continue learning are essential. In addition, these scientists illustrate that the regulatory field draws upon a variety of skills. Finally, and most importantly, Jones and Woodcock demonstrate that careers in regulatory affairs can be rewarding.