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Regulatory affairs: Pharma or Med Devices?

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Regulatory affairs: Pharma or Med Devices?

Postby SWT » Sun Aug 12, 2018 1:14 pm

I am a Ph.D. (Toxicology) currently working at the FDA for my postdoc and applying to jobs in industry. I have been interested in medical affairs and regulatory affairs for some time and I just received an offer at a company doing regulatory affairs at a dental medical device company. However, my experience from graduate school and at the FDA is in pharma and biologics.

I like regulatory affairs and would like to continue working in regulatory affairs in the future but I am interested in getting experience and then possibly moving on to other medical devices later.

Is getting experience in regulatory affairs in dental medical devices going to pigeon hole me away from working in other medical devices or from eventually working in pharma again?
SWT
 
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Re: Regulatory affairs: Pharma or Med Devices?

Postby PG » Wed Aug 15, 2018 4:56 am

Medical devices and pharma are two very different things from several aspects including regulatory. It is possible to move between the areas but it will be a barrier that you need to pass.

The barrier between dental and other medical devices is generally a lot lower and the similarities larger.

Having said this there are medical devices such as implants that in some ways have more in common with some pharma products than they have with other medical devices such as diagnostics. In the mind of the recruiter I have found that the main barrier often still is between Medical devices and pharma regardless of the actual work performed since there of course are differences.

Anything is possible and having experience from working with the FDA is a very good starting point for a regulatory career. Any type of network that you can build within FDA can potentially be very valuble going forward so work on those Contacts while you are on the inside.
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Re: Regulatory affairs: Pharma or Med Devices?

Postby SWT » Wed Aug 15, 2018 9:27 am

Thanks for your response PG, they are settling. Your comments on transitioning between medical devices and pharma reflect my initial feelings as well. I will definitely keep my FDA contacts in mine moving forward with my career. It is a shame that the FDA's hiring process is so awful or else I might have tried to stay here.
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Re: Regulatory affairs: Pharma or Med Devices?

Postby D.X. » Thu Aug 16, 2018 6:54 am

PG wrote: In the mind of the recruiter I have found that the main barrier often still is between Medical devices and pharma regardless of the actual work performed since there of course are differences.

Anything is possible and having experience from working with the FDA is a very good starting point for a regulatory career. Any type of network that you can build within FDA can potentially be very valuble going forward so work on those Contacts while you are on the inside.


Just wanted to build on this comment - these days there are very high siloed thinking behind medical device and pharma. The two are different worlds although there is a trend to have more and more similarities both organization wise and in some cases regulation wise -

You CAN be pigeon holed if you spend to much time what ever area you choose, depite your FDA contacts. Remember over time, your early experiences become stale even if you had small molecule (CDER) or biologics (CBER)experience.

So yes you'll get a good experience but be ready to port that experience sooner than later to pharma where possible if pharma is where you want to be.

I do believe your FDA experience would be great on the Rx side of pharma so wonder why you're not looking there? You've had experience being a I assume a pre-clinical assessor (pharmacology/toxicology) at a key Compentant Health Authority.

Good luck,

Dx
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Re: Regulatory affairs: Pharma or Med Devices?

Postby SWT » Thu Aug 16, 2018 7:18 am

Thanks DX that is what I was afraid of. I've noticed in some cases there are almost battle lines drawn between pharma and devices groups. That will be good to factor in to my decisions.

Currently I am actually looking within the FDA but job opportunities seem to come strictly from word of mouth here. I have only found a few openings from contacts who required slightly different experience (pharmacokinetic modeling) or one more year of a postdoc to come in as a GS13. My job here involved applied regulatory research rather than review applications (even though I reviewed a lot of applications in the process). I would love to stay here but can't find the opportunities.
SWT
 
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Re: Regulatory affairs: Pharma or Med Devices?

Postby D.X. » Fri Aug 17, 2018 3:20 am

SWT wrote:Thanks DX that is what I was afraid of. I've noticed in some cases there are almost battle lines drawn between pharma and devices groups. That will be good to factor in to my decisions.

Currently I am actually looking within the FDA but job opportunities seem to come strictly from word of mouth here. I have only found a few openings from contacts who required slightly different experience (pharmacokinetic modeling) or one more year of a postdoc to come in as a GS13. My job here involved applied regulatory research rather than review applications (even though I reviewed a lot of applications in the process). I would love to stay here but can't find the opportunities.


Its not really "battle-lines" per se, but more alot of siloed views and trend today for hiring managers and HR to be very narrowed on choice of candidates, that is they are biased - they want medical device experience if they are in medical device and pharma rx experience if they are in pharma, as they are biased they may have a view such as " that med device candidate won't do well in Pharma Rx, its too different")

Today it's really easy to become pigeon holed - and what that means is making lateral moves becomes more difficult.

Not to say it can't be done, it can, i've done it. People do it every day. It may just take longer and requires more effort, be it networking and self-investment. Don't let to be a barrier, just be aware.

You see there is alot of silos and biased thinkng out there, some of it is founded and relevant and can depend on the situation (i.e. you have no time to train you want a specific experience, no negotiation) and some of it is just bias. In Pharma is can be Rx and. OTC, say you're in OTC Regulatory and you want to go to Rx Regulatory, you find same views - yes OTC world is different, but you'll find some hiring manager with a view of .."well that OTC experience is nice,but i really need a Pharma Rx person the OTC person will take to long to train, experiene is not useful". And I can go on, can be even therapy area, Onco vs. say non Onco, can be Pharma Rx anf Vaccines etc. etc.

So just be aware and same job seeking priniples apply, you'll find someone who'll be open minded. You may need to take another direction for a while (i.e. go CRO for a bit) - but networking remains your best tool. Think about what you want and see how the opportunities map out.

And you may even like medical device who knows. But try it out and you know the risks and opportunities now - so good luck! When you're young it's the best time to explore.

Cheers,

Dx
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