So you want to be a regulatory affairs professional - here's how to get started:

Joan Kwong

Courtesy of Pat Dougherty

The academic two-step. For a PhD coming straight out of academia, the switch to regulatory affairs can be tough, but not impossible. "It's very doable," but it takes two transitions, David Jensen says. You'll have to start by moving from the academic bench to the industry bench, keeping in mind that the company is interested in hiring you for the research experience you have right now. Once you get your foot in the door, start letting people know right away that you're interested in regulatory affairs down the road, he says. Network within your company and take training courses. A transition could take less than two years. "Take those transitions one at a time and be patient," Jensen says.

You'll be fighting against the bottom line, so have thick skin. As a regulatory professional, you'll be dealing with high-level executives who don't have science backgrounds, and who might not understand the need for detailed safety testing and documentation. When Eduquest's Denise Dion first started working as an FDA investigator, she expected companies to be more controlled and concerned about detail. "People can't see how doing it right can help the bottom line," she says, "It costs at least 10 times more to fix quality problems that it would to prevent those problems." She often spends time convincing companies that getting it right the first time will save them money in the end.

Acronyms abound, so learn as you go or take classes. Before Joan Kwong obtained a master's in regulatory affairs, she moved from bench science to more of a regulatory role within the pharmaceutical industry. At first she says she was bombarded with "so many acronyms and specific descriptions of how things work." She'd encounter boggling sentences such as the following: "The critical upcoming tasks for this team include preparing for the FDA EOP2 meeting with CBER and the SAWP meeting with CHMP, updating the DMF, and authoring CMC sections of the IND and IMPD to support Ph3 studies." Kwong learned a lot of on the job, but taking a couple of classes helped polish her fluency in regulatory acronyms.

Start small. Working as a regulatory associate within a smaller company gave Denise Fairman a broader range of responsibilities. "It was an excellent opportunity," she recalls, and one that could help her if she decides to move to a larger company. At Lannett Company in Philadelphia, a manufacturer of generic drugs, Fairman prepares submissions for the regulatory aspects of manufacturing and marketing of several different drugs. She regularly calls up the FDA to answer questions about the submissions. Her friends who work in larger companies have more repetitive roles, she says, such as writing reports for the clinical phase of drug development. "With a small company you wear a lot of hats, which I found very interesting."