Regulatory affairs specialists work at the interface between business and government regulations, shepherding medical products from inception to market. It's a career track that can move you quickly from newbie to manager, reward you with weighty responsibility for important projects, and pay you more than what you would have earned if you had stayed at the bench.
However, a job in regulatory affairs (RA) is also one of the most difficult transitions for a postdoc or graduate student. Not only is it difficult to land an entry-level RA job, it's an incredibly demanding post. The work is very detail-focused, as it involves writing and reviewing documents that are thousands of pages long. It requires an understanding of science and business, as well as government language and procedures. The pressure can be intense--but it's important work, and for scientists with the right mindset it can be an excellent career.
Jobs on this career track are found in all sorts of companies: biotech and pharmaceuticals, medical devices, diagnostics, cosmetics, and even nutritional products. The best way to learn more about RA--after reading this column--is to set up informational interviews with people who work in the field. Also read the extensive feature on RA careers  that Science Careers published back in 2003. This month's column will start you off with a success story.
Shannon Strom is a senior regulatory scientist and associate director of regulatory operations at CATO Research  in Durham, North Carolina. She did her Ph.D. in pharmacology at the University of North Carolina (UNC), Chapel Hill . "One of my favorite experiences in my lab had been a collaboration with an M.D./Ph.D. who had a direct connection to patients in my area of interest," Shannon told me. "It really got me interested in helping people more directly, as opposed to simply doing another in vitro assay."
So as she neared the end of her Ph.D. in 2005, she focused her attention on opportunities and postdoc positions that could lead her to a clinical or drug-development position down the line.
"I took classes intended for those in drug development at UNC and participated in local meetings of both SoCRA [the Society of Clinical Research Associates ] and RAPS [Regulatory Affairs Professionals Society ], both of which have active chapters here," Shannon says. She also sought a Regulatory Affairs Certificate (RAC), which is normally pursued by RA professionals with at least a few years of experience in industry.
She initially felt that clinical trials management would be the best area for her to work in. She wasn't yet RAC-certified when she began her job search, but her experience working with patients during her Ph.D., and her networking in both clinical trials and regulatory circles, gave her an edge that made her very competitive for jobs.
After researching the field locally, she found the CATO Research Fellows Program . CATO doesn't do drug development; rather, the company provides services to the drug development teams in other companies. Those services include clinical trials management and U.S. Food and Drug Administration (FDA) new drug submissions and marketing applications.
CATO fellows train in an intense, 12-month program. Shannon was assigned the job of medical writer, where she helped assemble regulatory submissions. A full-time job isn't guaranteed at the end of CATO's fellowship; like many industry postdocs, CATO fellows are offered a job only if they've performed well and met certain criteria. Shannon was pleased when, during her 12-month review, she was asked to stay on to fill an open position as a regulatory scientist.
From day one, Shannon loved her job in RA. "Regulatory at our company is split into two categories: Regulatory Strategy and Regulatory Operations," Shannon says. "I have client interactions on the strategy side, and both client and FDA interactions on the operations side, and manage personnel in both areas."
Shannon's strategy work has included meeting with a client company to discuss the launch of an investigational new drug (IND) application. "This client has just begun the process of what will be a long road, and they need our advice on how to get their compound into the clinic," she told me.
On the operations side, her work is more about "the nuts and bolts of the process," she says. On the day I spoke with her, she had just met with a company about a marketing application for one of its products--the end of the line for a compound making its way through the regulatory process. She's been involved in all aspects of the application, which now consists of hundreds of thousands of pages. (In the old days, before electronic submissions, a marketing application would require an entire moving truck!)
The art is in writing the summaries that go into each section of these applications. Each is less than 100 pages long and must be evidence-based and very convincing. Shannon's company was instrumental in three of the 21 new drug applications the FDA approved last year.
Scientists working in RA cross the border between strategy and operations in the important area of product labeling--that little folded piece of technical fine print that is in every prescription you get from the pharmacy. Even when a company is just considering an IND, they have to be thinking about what the product's label will say. Shannon does a lot of direct negotiation with FDA about labeling and assists her clients with both early-stage and end-game labeling matters.
The label is the ultimate piece of succinct writing, as it is the final result of all those pages on the moving truck. Shannon writes these herself because they require her previous experience with the regulations that govern label content. Outside of this, most of the work she does with regulatory documents involves reviewing and editing the work of others.
Jobs in RA don't require a Ph.D. There are many RA associates in regulated industries with undergraduate or M.S. degrees. People who have jobs such as regulatory coordinator or regulatory associate are involved in administrative activities, such as information management, project tracking, or general support for the work that a manager or director is doing on a submission.
Those in higher-level positions do tend to have doctoral degrees: a Ph.D., an M.D., or both. It's the director of regulatory operations, or the chief regulatory officer whose name is on the bottom line of an important regulatory submission. That's a lot of responsibility considering the cost of a new drug is $500 million to $800 million or more!
But the real "must have" in RA isn't a degree, it's a desire to do detail work. "It's something you either love or you hate," Shannon says. "Anyone who has an interest in the regulatory field must have a very pronounced love of detail. It has to be evident in what you've done in the past and in your stated interests. While the regulatory elements of a job like this can be learned, if you can't manage tiny nuances of data in a multigigabyte document, you're in trouble."
Just about every job description these days calls for good communication skills, but Shannon says it's a serious issue in RA. "Nowhere in a company are written and oral communication skills more important than in this career. Sometimes I'll have 30 seconds or a minute to justify a recommendation with a busy CEO. If I can't communicate my important message in that brief time, the project doesn't move ahead. It's a completely unique field, one that stretches every aspect of your communication ability every day."
At the heart of an RA career is a belief that this work is being done to help people, many of whom have life-threatening diseases. This isn't work analyzing the genetics of a sea urchin; this is a job whose daily mandate is to help sick people.
As we were closing our interview, I asked Shannon to tell me about her original intent to make a difference in people's lives and whether she had found what she was looking for. She paused a moment and then told me about one of her proudest days at work.
"I had a chance to meet those whose quality of life had changed so dramatically because of our project," she told me. "These were very ill patients, bedridden, and who couldn't feed themselves. To see their joy upon being able to sit up and eat on their own, ... it was simply remarkable. It was an experience that I will never forget."
Photo (top): Guido E. Alvarez