Is it difficult for a postdoc to get regulatory job without degree in regulatory affairs?

[Mary K.]

Hello,

I am a 5th year postdoc in neuroscience and its quite sure that academics is not a place for me to thrive. I was on a visa and thats why I had to hang in there. Now I am free to apply for a job I enjoy. I am a people person with excellent project management and coordination skills, and I don't want to be in research/wet-lab job. I spent a while to choose what I love to do and capable of. Two fields that really match with my interest and skills are medical affairs and regulatory affairs. I applied for medical affairs jobs, specifically medical science liaison (MSL). I was managed to get 2 interviews, but its a tough sell for a postdoc as MSL competition is fierce, needs medical\healthcare experience, and companies mostly prefer native speakers.

While looking at regulatory affairs jobs, I see that there are online courses and regulatory certification (RAC) I can take to build knowledge about the field. My question is, is that necessary to get a job for a PhD-postdoc in regulatory affairs field or should I take a degree such as MS in regulatory affairs?

Thanks for your time.

[Dave Jensen]

Mary,

I would fight as hard as possible, if I were you, to get a job first and not go to additional education, another postdoc, etc. Really, there comes a time where people just have to say "I've had enough" and put 200% effort into the finding of a job. The economy has, after years, finally picked up steam and jobs are out there. That's not to say that there aren't still too many of certain scientists in the market, but like everything else, the "early bird gets the worm" or the "squeaky wheel gets the grease," or whatever tired phrase you want to use to describe the fact that the most active job seekers seem to succeed.

There's an article about this track in Tooling Up that you ought to read, because the interview was with a person like you and she talks about how she got into regulatory. It was about 2 years ago -- still current enough to be of interest (http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2009_09_18/caredit.a0900112).

The RAC certification is great, but all you need to do is to be "in process", training for it, and you'll stand head and shoulders about everyone else who is applying for those entry level Regulatory jobs. Or, you might have to take a job in a technical staff doing work for the regulatory submittals, and then move over sideways to the RA group once you've had some company experience. That's always a particularly good path. The biggest fear you will find by employers will be the "can this person think beyond academia" concern that companies have. So many people with advanced life sciences degrees from academia often know nothing about the world of business, and it "shows" in their interviews and in the approach they take to finding a job. Just break that cycle if you can. Read about regulatory, go to a few events or networking meetings for RA staff, stay in touch with the RAPS website, and so on. Just by building your network around that interest, you'll hear of entry level jobs.

Don't forget the world of regulatory consultants. There are a LOT of RA consulting outfits, some of them are one-person operations. Even a sole operator who has a good list of RA clients can use help and that's an excellent training ground. Even if you were to go in with only a 10-20% increase in salary from your postdoc (a real bargain for that consultant employer) it would be worth it because after a year or so you'd have great experience.

Come back and let us know how you did.

Dave Jensen, Moderator

[Mary K.]

Thanks Dave. In fact your "Tooling up" article encouraged me initially when I started thinking about it. Your message is really encouraging and I am going to give it a great effort. I will definitely come back with the results.

[Dave Jensen]

Great! Mary, let us know (or me personally via internal SC.org email exchange) what part of the country you are in and what your science niche has been. Perhaps we have friends or referral sources for you.

Dave

[D.X.]

Hi Mary,

Couple points to add to Dave.

Don't forget to look at the major CROs. Most if not all are offering Contract Services beyond Clinical Trial Operations to include Regulatory Affairs. As Dave mentioned, there is always need for the highly operationalized and technical content generators, which can serve as an entry-level role for you. Some stressors in RA is that a Health-Authority may come with an inquiry where you only have 48 to 72 hours to respond, or you have very tight timeline to submit a variation or update. But RA, is a nice role you keep the big picture in mind, you're the one placing a key part in getting patient access to medication/ no dossier = no license = no market access.

Just to mention the skills and day to day actions for RA and Medical Affairs especially MSL roles can be very different and each does require a certain personality and the type of stresses you can manage.

MSL role is more of a communication role. You won't spend time writing technical documents and pooring over scientific dossiers and study reports, etc. You'll be speeding time reading the data you need to know so that you can communicate it and have a credible discussion, not in writing, but verbally to HCP/KOLs. Relationship building and networking skills is fundamental; if walking into a medical office on a cold-call trying to meet a HCP is not your thing, then this job is not for you.

Knowing how to run a meeting and deliver presentations of data to diverse audiences such as nurses, MDs, and Pharmacist will be of importance. So you must feel comfortable in front of a group and be adaptable to many presentation environments; for me I one presented a huge university hospital auditorium where real-time video/audio was sent out to 3 satellite sites and also presented in medical office lunch rooms. Can you be OK with that? Can you also be OK with a KOL demonstrating aggressive behavior?

No different to RA, you have to start someplace, maybe a MSL in todays environment is tougher compared to when I did it. But...I did go work for a 3rd party vendor doing grunt medical writing work for a couple pharma clients for a few months before a MSL role found me. At least I could talk a bit about data communication from a clinical/pharma point of view.

So very different activities requiring different skills and personalities. Do weight that option as well, are you a technical person who likes writing and interpreting high-science data contained in technical documents, data-bases extraction that can yield interesting results, and process? where you have super high impact in terms of patient access to medication and thus commercial success?

Or do you like people engagement, presentations, gathering data knowledge for scientific discussions, learning marketing elements, where your win changing HCP behavior to improve patient outcomes by communicating science via meetings/presentations? etc.

The good part is you have focus 2 focus areas; Don't give up but also consider there are stepping stones. And consider your focus areas are quite different in terms of skills, required strengths, and where you feel comfortable.

Good luck,

DX

[Mary K.]

Thanks DX,

very valid points and you really split the hair for me to understand what skills and personalities goes where. The reasons why I applied for MSL are exactly the ones you have given. I have been passionate about communicating science, interpreting complex data and always gave terrific presentations. During my postdoc stint I established collaborations and always lauded for team work and relationship building. So from these 2 focus areas, my heart goes with an MSL role at the end. But from my basic science research background, I think a direct jump to MSL is unrealistic. So I am planning to take entry-level jobs and earn my way up from there in couple of years.

[Mary K.]

Great! Mary, let us know (or me personally via internal SC.org email exchange) what part of the country you are in and what your science niche has been. Perhaps we have friends or referral sources for you.

Dave

Thanks a lot Dave for your kind and great gesture to help. I sent you an email with the details.

[Bright B.]

Mary,
Don't give up!!! At this point you don't need RAC certificate or a master degree in regulatory affairs. It might be a waste of time and money. There are company like J&J, Covance and other that offers programs for PhDs looking to enter regulatory affairs. The FDA also have a program that pays well. But depending on how well you hassle you can get a job. I have done this successfully with less than a year postdoc. I went from a 7 months postdoc to a regulatory advisor position in industry. My background was in pharmacology and Toxicology with a neuroscience emphasis. With 5 years postdoc you should be able to get a position. You just have to find your own way of marketing yourself. I also have an accent. I was raised abroad. There are a lot of paths that can lead you to an RA position or research position in the industry side. Don't focus solely on pharma industry. You should also look at CRO, Chemical manufacturing, chemical industry and consulting firms. I'm at my company for about 8 months now.