Editor's note: Joe Tringali is a professional recruiter who has done work in the area of regulatory affairs. We asked him to start by describing his experience.
Joe Tringali: Over the past 15 years I have taken a dual path. ? First, I provide traditional placement services within the biotechnology and pharmaceuticals industries, across all functional areas. Secondarily, as clients request, I provide onsite consulting services in the area of employment, developing effective strategies, educating about changing market conditions, and hopefully improving the overall effectiveness of a firm's recruiting programs.
It's rare for a firm NOT to have needs in the area of regulatory affairs. When I am first contacted by the client, they are usually frustrated by their lack of recruiting success in this area. It has little to do with the organization itself and more to do with the dynamics of supply/demand and the effectiveness (or lack thereof) of its recruiting message and understanding of what it is they are "selling" to potential candidates.
In other words, I've found that companies have a hard time finding people to fill their regulatory affairs roles. That's good for people who want to work in the field.
Regulatory affairs professionals work either in government or in the private sector, in compliance and related activities. I haven't done any hiring for government agencies in regulatory affairs. Companies have critical hiring needs in the areas of filings/submissions, compliance, labeling, etc., and I have assisted with hiring in the private sector in many of these areas.
NW: Two of our essayists for this feature--both working in high-level regulatory positions--have suggested that a science background is very useful, if not essential, for these jobs, but that past experience or formal training in regulatory issues isn't. Do you agree with this assessment?
I would agree with the assessment, with this caveat: Until recently, there have been few formal training programs in the area of regulatory affairs. It was a career that individuals often ended up in by default, because compounds moving through the pipeline were now being submitted to the Food and Drug Administration and a need arose for someone to steer the regulatory vehicle. Someone within the organization was usually asked to take on this important role. The science background helps with the technical aspects of the science and provides credibility in your interactions with government agencies.
It's true that few people have formal training in regulatory affairs, but as formal training programs continue to grow, they will become a better source of viable candidates for companies, especially given the supply/demand dynamic for these individuals. The ability to take the theory of the function, and apply it in real world situations, will be invaluable; internships, industrial postdocs, etc. will increase a candidate's marketability.
NW: What kind of people were you (and your client companies) looking for?
Typically, I get the call for the more senior people, industry-seasoned professionals who can chart a successful regulatory strategy for the organization in question. Such a person will have firsthand knowledge of what strategies work or don't work, will probably have government agency contacts at this stage of his/her career, and will be able to provide mentoring capabilities for the less-seasoned staff members. The typical profile is for someone with a Ph.D. and, depending on the level of the position (manager, director, VP), anywhere from 5 years to 15 years of related industrial experience.
If a firm wants to train someone they will most likely tap their own internal resources. Why not take a highly regarded employee who may be interested in the area of regulatory affairs and train them, as opposed to someone who would be new to both the organization and the function?
NW: You've indicated that when a company brings you in it's almost always to hire someone with lots of experience into a senior position. That doesn't describe the typical Next Wave reader. Our readers are typically science-major undergraduates, grad students, postdocs, along with a few professors and scientists working in staff positions in other fields. What can, say, a science grad student do if he or she wants to test the waters in regulatory affairs?
First off, before they go too far down this road, they want to make sure it's an avenue they really want to pursue. The best way to do this is to talk to people who work in regulatory affairs. Don't just focus on the positives--explore the negatives as well.
When a company wants to hire someone without regulatory affairs experience, it makes the most sense to do it from within. So one strategy is to get a job working for a company some other way--maybe a research position--then, when an opportunity opens up in regulatory compliance or a related field, make it known that you are very interested. Get to know the professionals in your firm's regulatory affairs group, make them aware of your desire to join their ranks, ask if there are small projects you might do in your spare time to learn the business. Get a better idea of what's involved in regulatory work in a corporate setting before you make the change.
Another approach is to rewrite your CV; I don't mean to rewrite it literally, but to change its focus by seeking out experiences that make it clear that you view regulatory affairs not just as a poor alternative to a research career, but rather as a positive step toward something you truly are interested in. He/she could join the Regulatory Affairs Professionals Society (RAPS) and, if practical, get involved with the local chapter. This might serve several purposes. It would make available to you the society's membership directory (talk about a networking opportunity!). The local chapter would have you sitting at the same table with local professionals who will learn of your desire to make the move into their field.
Additionally, you may find yourself with opportunities to volunteer for small, related projects, all of which would serve to change the face of your CV. The newer version will not only show some related experience, but a distinct intent on your part to join the ranks of regulatory affairs professionals. This is not meant to imply that you would soon be qualified to lead an entire regulatory function. You will have made, however, the crossover into your new chosen field. Congratulations!
Another approach is to take related coursework and perhaps gain some related certifications online. [Eds. Note: San Diego State University--see the article by Larry Gunderson--offers all of its regulatory affairs coursework over the Internet. The Web site of RAPS offers detailed information on certification, as well as distance-learning opportunities. The society also maintains a list of active graduate degree programs in regulatory affairs.]
The same applies for folks working inside an organization. They can show the in-house regulatory group the same intent by coursework, memberships, certifications, and by volunteering to do small projects for the group, so long as it doesn't interfere with the individual's own responsibilities. The message has to be clear: "I am investing time (and money) into this transition because I know it's what I want to do; I will be doing it soon, hopefully for you!"