How to get in Regulatory Affairs? Can anyone help

[S. Guy]

Hi all,

I have a bachelor's in Political science, however I really want to transition into an RA role for medical devices/pharmaceuticals. The problem is, there is literally no entry level role for this field, all of the RA jobs I saw required a minimum 2 years of Regulatory affairs to even be considered for the position.

I even tried calling the HR department to ask for a few medical device companies and pharmaceuticals, and the lady there said she'll email one of the recruiters to ask how to get in, but no reply. This royally sucks. Does anyone have any clue as to how to break in this industry? I've been looking for a while now. Any insight is appreciated, thanks in advance

[Dave Jensen]

Employers often hire people for entry level Regulatory jobs from the ranks of their existing staff. They'll sometimes reach into the market as well, but I've always found they take people who have been technically trained. Your Political Science education may not be well-suited for a regulatory entry level job, but you should network to find out. You may want to talk to some people who are currently in Regulatory posts to get their views, but I'm afraid that even if you landed an opportunity, you may not have much of a career track in front of you because more senior RA staff are all people with advanced life sciences backgrounds.

See the Regulatory Career Track article on this site, at http://www.sciencemag.org/careers/2009/ ... reer-track.

Dave

[S. Guy]

^That's the part that I'm not sure on, because I know RA requires a bachelor's, but it doesn't have to be life sciences, you're usually dealing with 510k files, the FDA, substantial equivalent products and MS Excel which I'm good at. So why does there need to be a life science background? You aren't doing reactions or anything scientific like that. Several jobs for RA showed that a bachelor's was required, but didn't state it needed to be in physical sciences which would make sense if the work is administrative in scope
Several people had BAs in Communications or liberal arts from their Linkedin profiles that I saw, and are in RA.
Also, via the article you wrote an RA adviser said- "But the real "must have" in RA isn't a degree, it's a desire to do detail work." And that, is what I do and enjoy, as I also have a degree. More was mentioned in the article, to wit: "This isn't work analyzing the genetics of a sea urchin; this is a job whose daily mandate is to help sick people" - unless you're a nurse or clinician I still don't see why a life science background is needed.

Does anyone else know of anything on how to break in? My only other guess is to enter through a non-RA role with company, do well in it, then after some time ask to internally move to RA. My local university offers an RAC (Regulatory Affairs Certificate) and I am more than willing to do it if it lands you an RA role, but I'm confident companies want the industry experience over a freshly minted RAC certificate that someone paid a lot of money for, to no avail. Thoughts?

[Gord H.]

I'll provide my perspective. I'm currently in a senior RA role at a large global pharma company. RA has evolved and has become more than just administrative work. There are 2 tracks in RA, RA operations and RA strategy. In my role I oversee a global RA team which includes RA operations and RA strategy colleagues.

RA operations roles focus primarily on the administrative aspect of the function and includes many of the things you described as well as tracking, managing and making submissions to health authorities. Because of the administrative nature of this work a life science degree is not necessary. Most of my RA operations colleagues do not have science degrees.

At a high level, RA strategy roles are leadership roles on matrix drug development teams which focus primarily on devising and implementing a plan to achieve a drug's target product profile. To be successful in an RA strategy role you need to have a good understanding of all aspects of drug development (clinical, clin pharm, non-clinical, stats, some CMC, etc) as well as key regulations, guidelines and policy. This is critical to be able to identify pathways to regulatory success (for instance IND clearance, expedited development pathways, NDA/BLA acceptance and approval, etc) and lead drug development teams to overcome hurdles or barriers to regulatory success. Also a big part of an RA strategy role is being the lead for FDA/health authority interaction. Consider that health authorities make decisions based on their evaluation of data that's generated from scientific, non-clinical and clinical studies, it would be difficult to be a successful regulatory strategist without a good understanding of the science. This is why it is useful to have a science background/degree, and in many cases senior regulatory strategy folks have advanced science degrees.

So back to your question, whether it's strategy or operations you're interested in the best way to break in is to network. Considering what you said about your interests and abilities I think it would be easier to break into an operations role. For such roles as long as you can demonstrate you're detail oriented, organized, and knowledgeable of MS software and publishing software you meet 70% of requirements for an entry level role. From my experience the internal industry folks transitioning into RA are not going into operations. They tend to be going into strategy so you should not have much internal competition if it's operations you're interested in.

[D.X.]

To add to great post by Gord,

In Terms of where to look for entry level jobs, I advise you first look at CROs who provide RA services/or RA 3rd Party Services Providers for RA operational roles.

As Gord mentioned, there is alot of admistrative and project management aspects to the entry Level positions, much of These very opearational/admistrative roles is outsourced by the big and medium sized pharma companies. Over course there Needs to be someone overseeing/coordinating that from the client side (someone with experience with RA operations) but for entry Level that's where I recommend you first look for your initial opportunity.

Start with the established CROs with RA Services for Job opps while you work to understand if any relevant other non-CRO RA specific service providers.

I can't comment on device, i don't know how things work on that side.

Best,

DX

[S. Guy]

Thanks for the replies. Gord, at this point I definitely would like operations since that's what I'm good at, and prefer usually. Where would I go to "network"? I'm just unclear on how to, as my networking isn't great.

DX- I don't know why CROs really are, Googled it and found Clinical Research Organizations? My goal is an entry level RA role, and no medical device company or pharm company had anything entry level after several months of looking. And I'm not sure what the CRO or non-CRO stuff is you mention, can you please explain? And yes, I would like a medical device company, but am definitely open to pharmaceutical one way or another, just anything RA, entry level. Problem is its no where to be found.

[D.X.]

Hi S.Guy,

Yes CRO is for Contract Research Organizations - they are "contracted" by the pharma or device Company to conduct the operational aspects of many R&D functions to include Clinical Trial Operations on behalf of the Company.Whilst, the Company is still the "Sponsor", but ok that's a bit techinical.

Historically they started off in R&D aspects (Trial operations) targeted for Outsourcing. But now many of These CROs, especially the big global ones offer Services beyond Research to include commerical services (i.e. Marketing activitie and contracted sales Forces) as well as Solutions for RA and Drug Safety to Name a few. So they're basically I guess now Contract Service Organizations where you as a Client can get anything. They have competencies to nearly be stand alone pharma companies but that's not their operating model.

The big ones include Quitiles, Paraxel, inVentiv, Covance etc. and you can find some small ones. And as mentioned there are some speciality. ones with narrowed services such as for RA and Drug Safety etc. etc.

As they are more operationally focused with some stragetic services offered, they may more entry Level opportunities as they Need Folks to do some grunt work. Since they are so big and have may different functions (servicies) potentially you could grow in a CRO Setting but I don't have first Hand experience there. I do know that some Senior pharma People may Transition to highlevel CRO roles as a matter of career decisions and many in CROs also Transition to pharma over time.

I have worked with a couple of the above.

There are some "Management Consulting" firms that do offer some services to pharma such as Project Management for Drug Safety in one experience I had, one firm was Accenture - though that Service came from a an affiliate of that firm in Country noted for outsourced services - non the less see what you find.

As far as networking well, try Linkedin. I don't know much about where I can guide you there.

Best,

DX