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?
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.