To move to Regulatory Affairs or Not?

[SVG]

I am a materials/biomedical engineer that has spent the last 10 or so years doing basic laboratory research, first as a graduate student and postdoc in academia and most recently as a fellow with the Center for Devices and Radiological Health at the FDA.

I made the decision during my postdoc years to move out of academia. I was lucky to receive the FDA fellowship at that time; it afforded me the opportunity to continue to bolster my scientific credentials while providing the chance to learn and engage in the regulatory review process.

The two year fellowship ended recently, and due to familial/geographic constraints I had to officially leave the FDA. I've relocated to an area with very few medical device companies within commuting distance. Though I really enjoyed learning and participating in the regulatory review process (I was the lead reviewer on a handful of files), my instincts are still inclined to work in R&D. Over the last six months, I've made internal connections at a number of mid- to large-sized med device firms in the area, but only received interest from hiring managers for regulatory affairs positions. I decided to interview for these positions and now have two offers.

Though I've talked to some former colleagues who have made the transition, I remain conflicted. Thus, I wanted to ask the forum members who have made the transition from PhD scientist to RA specialist for feedback.

What made you decide to make the jump?
Did you find the work intellectually challenging?
What are the most challenging aspects of the job?
Which skills as a scientist were the most useful? The least?
Do you miss being at the bench?
Can I go back to R&D if the position doesn't work out?
Any other advice would you give to someone making that transition?

I know RA is an area in high demand, with many opportunities for learning and growth. But I am nervous about taking the plunge.

Thanks.

[Dave Jensen]

Hi SV,

From a recruiter's point of view, I'd say you'd be "set for life" if you go the RA route. Or, another way to put it is that you'd probably never have a difficult job search. There's forecasted need in this area for the next couple of decades.

The lure of research will remain with you but you'll find lots of opportunities to be challenged and rewarded by in Regulatory as well.

See the article here for a descriptive run down of one person's move from research to regulatory, http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2009_09_18/caredit.a0900112

Dave

[ATG]

Hi SV - I've occasionally visited this forum but have never posted, mostly because I am in the Ag biotech industry so the topics here aren't always relevant to my expertise. However, I do feel compelled to respond to your post, because Reg. Affairs is a comparatively small area, and it can be difficult to find information. Also, like you, I have a Ph.D. in biomedical engineering, though I‘ve only worked for one company in my career - first in R&D, now in Regulatory Affairs.

What made you decide to make the jump?
- Looking for a change in career path; in my R&D position, I started up a high-throughput screening lab, and I found the maintenance of a lab less interesting than the start-up activities. The decision to switch Reg. Affairs itself was not intentional, though; it just happened to be posted at the right time and in retrospect I did not quite know what I was getting myself into.

Did you find the work intellectually challenging?
- Yes! What I love about my job is the intersection of science, getting a product out to market, public policy, laws/regulations, and people. The other aspect that I love is that I never know exactly what will cross my desk/screen on any given day. Some days, it's reading the technical parts of a regulatory submission, the next day an international trade issues might pop up, another day it may be discussing regulatory strategy for a cool new technology that don’t fit under the current regulations. Some days I have to call an agronomist to find out how farmers deal with problematic weeds in their corn fields, and for a different product, we will be working with entomologists to study how insects move and mate in the field to figure out how to make a good model to submit to the agency. Or I could be pouring over proposed rules from an agency and talking to people in the various parts of the business to figure out the business implications of new regulations, and then writing comments to the agencies on the proposed rules.

What are the most challenging aspects of the job?
- Communication. Knowing who to tell what, when. I include both internal and external communication here. Internal is difficult because the nature of Reg. Affairs is that you are preventing issues from arising, so success is when nothing happens. It can be difficult for the organization to value your work when everything goes as planned. My analogy is that Reg. Affairs function is like that of the sweeper in curling - you're sweeping debris out of the way and making the path on the ice smooth so that the stone will reach the target, which is approval. If that makes any better sense.
Which skills as a scientist were the most useful? The least?
- Most useful: being able to grasp technical (and other) information relatively quickly. Not enough to truly understand it, in many cases, but enough to be able to get at the essence of an issue, in order to figure out how to address it in a way that is science based, and will satisfies the regulatory agency, stakeholders, etc. and your business.
- Least useful: None that I can think of.

Do you miss being at the bench?
- No.

Can I go back to R&D if the position doesn't work out?
- Probably depends on the company, but for my company, I'd say yes (as long as you weren't out too long).

Any other advice would you give to someone making that transition?
- You can probably tell that if your personal strength is that you like to understand things deeply, and it would bother you to be superficial, this is not a good fit. Reg. Affairs, at least in my industry, is a mile wide and an inch deep, so make sure you’re okay with such a work environment.
- Make sure you have a mentor for this type of position, and talk alot. Each agency has its own personality, and you need to really understand how an agency makes decisions and why, in order to be effective. This means knowing the history of the agency regulations and policies, knowing the people/personalities there, etc. It will be easier for you to be successful if you have some guidance.

Sorry about the long post, but hope this was helpful.

[Dave Jensen]

ATG,

That was an extraordinary helpful post.

But, I'm curious . . . Why do you feel Ag Biotech is excluded here? That's one of my company's major areas of expertise. I don't ever feel like the forum is slanted to one type of science. I would think that it's perhaps a bit too life-sciences oriented, and perhaps a physicist would feel a bit like a loner (although I hope not) but it certainly isn't healthcare centric. Ag Biotech is an absolutely critical field for the future of our planet. Please, with this quality of post, we don't want to lose you. Hang around and post more often! I know a number of others who are in Ag Biotech or Plant Sciences, such as PC, one of our frequent posters.

Dave

[SVG]

Thank you ATG for your thorough and helpful reply, and Dave for providing some additional perspective on the job market. I appreciate it.

[ATG]

Hi Dave,

I wanted to respond to your question above. In fact, I think this forum is extraordinarily welcoming to all fields, so I apologize if my post read as though I felt AgBiotech was excluded - that's not it. It is more that when I scan the topics, I do not feel qualified to opine on many. However, I am happy to contribute when I can.

I often refer the Science Careers site and this forum to students that I mentor via MentorNet (a terrific e-mentoring program for students, if I may put in a plug) so this is that main reason I visit - looking for helpful information for protege's. The diversity of topics is really useful for them!

SVG, I realized after I posted that my last piece of advice isn't really applicable for you, since you come from FDA. In your case, my advice around a mentor is slightly different. If the RA position means you'll be interacting with your former FDA colleagues, your mentor can help you navigate the new relationship you'll have with your "old" friends. They are still your friends, but you're now in a different place, and there's a certain distance that has to be respected. What that acceptable interaction looks like is probably influenced by your company culture, along with the usual legal and perception (FOIA!) considerations that companies have to be concerned with. If you're not going to be interacting with former colleagues, then this is not as tricky a space.

Good luck!
ATG

[Dave Jensen]

Thanks for your support ATG!

[S. P. Harmacy]

Please let me know..is there any basic experience required for moving to RA. Presently I am doing my PhD in analytical chemistry (finished 1.5 yr almost). If any company that provide volunteer experience?
Thank you

[ATG]

Hi S.P. Harmacy,

Typically the people I meet who work in RA have science backgrounds or law backgrounds, so an analytical chemistry degree is appropriate (i.e., won't close doors). Otherwise, the basic requirements will not surprise you - excellent communication skills (both verbal and written), interest in law, regulation and policy.

I don't know of any companies that provide volunteer experience. In my experience, people who are hired for Reg Affairs positions tend to have some kind of experience either in the company or in the industry. There are sometimes positions available for new hires. One student I worked with obtained a position at GE Healthcare, where they had a Quality Regulatory Leadership Program (QRLP) - this was back in 2011 so not sure if the program still exists or not. Another possibility is to look for positions in product stewardship or regulatory science (a good possibility for analytical chemists). Experience in either area can position you to move to Reg Affairs later.

Hope this information will be helpful as you begin your job search!

ATG