I've been asked a number of times how one breaks into the regulatory field, so I thought it might be helpful to share some thoughts on what I look for in an RA hire. Your mileage may vary.
Dear Friend,
It's exciting to hear that you are interested in Regulatory Affairs. This is an engaging and dynamic field that makes a real difference in the quality of medical information.
Entering the regulatory profession is pretty simple: you need to get a job at the bottom rung of the profession and be willing to work like heck for at least five years doing un-glamorous tasks. It can be difficult to land that first job, but there really isn't a better way in. You either work your way up by developing a hands-on appreciation of how the process really works, or your time and opinions aren't going to be worth very much.
I apologize if that's too blunt, but it's something I think you should know if you're interested in entering the profession.
Getting a start in regulatory is all about getting that first job. So how do you get it?
There aren't any carved-in-stone requirements, but let's start with a bachelor's degree being a pretty solid minimum. Undergrad science degrees are useful, but not required (mine is in music). Graduate degrees in science may also help you land that first job. Many (if not most) RA professionals come from the lab. Not only is it helpful to be conversant in the science that underlies your business, but having a lab job may put you in a position to find out about those entry-level opportunities in RA. Such jobs are seldom advertised.
Not all degrees are helpful, however. There are also degree programs in Regulatory Affairs. An RA degree could be just the thing to help you get that first (or second) promotion, but it's not a very helpful way to get started. This may seem counter-intuitive, so allow me to explain.
Breaking into RA is all about that first job and what you do with it. The kind of people you can learn from are not looking for their junior staff to provide opinions or a strategic vision. They're looking for grunts to take meeting notes, run copies and organize three-ring binders. People who have drive and a willingness to learn from this kind of work can go far once they put in their time. You can learn a lot from being a grunt on a decent-size application.
Having a degree in RA too early may hurt you because it could make it more difficult to land your first real RA job. You may have read regulations and warning letters and studied cases, but you really don't understand what this profession is about until you know what it really means to manage an application that spans a dozen or more binders. You can't understand what manufacturing processes or materials handling really means until you have set foot in a manufacturing or warehousing facility. Regulatory isn't just about what's written down in the CFR. It's not even primarily about what's written in the CFR. You need to immerse yourself in the business for most of a decade to even get a sense of what's really going on.
Even if you aren't expecting your RA degree to be a shortcut, you're still in a bit of a bind. Neither you nor a hiring manager will think that entry-level work is the right choice for someone with an advaced degree in the field... but you're not qualified yet for anything else. Having a degree without any experience is a tough sell.
I don't mean to slam RA degress or education in general. I'm just saying don't overlook the importance of doing the admin work. I'm reminded of Thomas Edison's old quip: "Opportunity is missed by most people because it comes dressed in overalls and looks like work." Tempting as it may be to skip that first job, you owe it to yourself to put in the time if you want to develop the expertise.
Your friend,
Mya
