Regulatory Affairs or Medical Information

[brsadmd]

I have offers from Regulatory Affairs (RA) and Medical Information (MI) in industry. Med Info (smaller company, ~1500 ppl) pays much higher (20-25K) more in a lower COL area (though both areas are pretty higher overall). Accounting total compensation, potential coworkers, the 2 are pretty much even

I'm factoring in job stability between the 2 fields, opportunities to advance, what would be more useful in transferring skills to another field (say from RA to another field or Med Info to another field), and demand (if lose job in RA or MI, which would be easier to find another job).

I'm kinda leaning towards RA even though it pays much less. It's harder to break into RA for a new grad than Med Info (imo) and seems to be higher demand for RA than MI overall, especially for experienced RA professionals. I'm thinking more of my whole career and not so much the initial starting salary (I have no debt at all)

Any thoughts?

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[lord999]

Think you answered your own question. The other question I would ask myself is if you were laid off, are there other companies in the local market that you can work for without relocating? That would factor into my decision for either field, but especially RA as those departments ebb and flow with FDA and Department of Agriculture regulatory enforcement perception. But, you do choose between two good fields, good luck!

 

[brsadmd]

Think you answered your own question. The other question I would ask myself is if you were laid off, are there other companies in the local market that you can work for without relocating? That would factor into my decision for either field, but especially RA as those departments ebb and flow with FDA and Department of Agriculture regulatory enforcement perception. But, you do choose between two good fields, good luck!

lord999, thanks for the reply. I was wondering if you had any more insight in the 2 fields? The RA role is quite better location wise than Med Info but I've heard things like RA is better for job security and if you're in RA you're set. But I never heard why exactly that is. I look at job postings and there just seems to be more RA postings than Med Info, many of them requiring experience (so most people who get into RA already work in industry). I also don't know why RA is harder to break into than Med Info for a new grad. Wondering if you could shed more light on the field?

 

[lord999]

My interactions with the industry is that Med Info is actually safer as it's less subject to Finance cuts (RA has the problem of Office Space in terms of having to justify their position, they don't produce anything, they prevent things from happening). I've seen both go through periods of turnover to get better productivity out of the remainders and rightsize salaries (think of it this way, you are probably taking some job from someone who didn't run fast enough rather than a new position). Location for it matters, and if they are willing to hire a new grad, then you're either better than most at selling yourself as decent, or they have not-so-nice intentions to use you for donkey work or something politically explosive that the regulars won't touch or that your predecessor blew up. But, it's a start! It's better to take over from a screw-up than it is to be the one after the hero.

 

[Argentium]

I have the opposite experience vs lord999 regarding regulatory affairs job security, but you didn't specify what kind of RA you'll be doing, so it definitely depends on that. RA is pretty broad and ranges from advertising/promotion to CMC (manufacturing) to global regulatory strategy.

Not knowing exactly what the job you're describing entails and generalizing a lot, my opinion on reg is that it is a fantastic career path with lots of different options from an expertise/functional perspective (see above), geographic PoV (US vs EMA vs Global), and also type of company (CRO, Big Pharma, Biotech).

I expect regulatory to only increase in importance and complexity as companies are increasingly using innovative methods to satisfy regulatory requirements and the agencies seem to be more open-minded these days. In only the last half decade, we've seen a new pathways open up (Priority, Breakthrough), the emergence of big data (historical control arms, retrospective real-world evidence for regulatory approvals), and a lot of innovative submissions/approvals (tumor-agnostic oncology approvals, CART, gene therapy, etc.)

 

[brsadmd]

I have the opposite experience vs lord999 regarding regulatory affairs job security, but you didn't specify what kind of RA you'll be doing, so it definitely depends on that. RA is pretty broad and ranges from advertising/promotion to CMC (manufacturing) to global regulatory strategy.

Not knowing exactly what the job you're describing entails and generalizing a lot, my opinion on reg is that it is a fantastic career path with lots of different options from an expertise/functional perspective (see above), geographic PoV (US vs EMA vs Global), and also type of company (CRO, Big Pharma, Biotech).

I expect regulatory to only increase in importance and complexity as companies are increasingly using innovative methods to satisfy regulatory requirements and the agencies seem to be more open-minded these days. In only the last half decade, we've seen a new pathways open up (Priority, Breakthrough), the emergence of big data (historical control arms, retrospective real-world evidence for regulatory approvals), and a lot of innovative submissions/approvals (tumor-agnostic oncology approvals, CART, gene therapy, etc.)

Wow thanks! That was really insightful and elaborated what people have been saying about RA.

More specific, it's RA strategy. It's not reg writing (not sure if this is being phased out or automated...I've seen online posts about it), not CMC, or advert/promo. It sounds that RA is great overall. Would you happen to have more insight into RA strategy in particular? Is it possible to rank the specialties of RA in any way?

I'm wondering how transferable and easy it would be to find other opportunities within or outside RA at other companies should there ever be restructuring or downsizing for someone with RA experience. Any thoughts? Thanks

 

[Argentium]

I'm going to caveat that I'm not in regulatory affairs or medical affairs/info (though I have worked with them closely in the past) so feel free to take this with a grain of salt

I think of regulatory in the framework of strategy vs execution/application-focused and there's a lot of gray in between. Some random thoughts for your consideration as it relates to regulatory:

• Advertising/Promotion probably leans more towards application/execution-focused as you're focusing on whether commercial activities are meeting the standards set in place by the label. Worth noting that the ad/promo teams oftentimes don't even sit in the regulatory group (which typically rolls into the R&D organization) but rather the compliance team (which rolls up into the general counsel). As lord999 mentioned, this is a cost center and actually can be perceived as dampening the effectiveness of other groups (e.g. marketing, sales)
• Global Reg Strat. has the ultimate goal of getting a product on to the market and working with regional teams (FDA, EMA, PMDA, etc.) and the cross-functional development team (clinical research, development team, biostats, etc.)
• IMO, you're most effective in reg strat. if you have strong FDA experience (given majority of product revenues come from here) and secondarily EMA experience - I've seen people spend 2-4 years in each group before moving on to a global role
• Your credibility in reg. is based on the # of submissions (IND/NDA) and launches you're able to get lead ... TLDR: get yourself into a hot therapeutic area (e.g. oncology) in a company with a lot of upcoming launches

Regarding transferable skills, I don't know many people who have transitioned out of regulatory strategy but I'm not sure if that's because they were unable or because they didn't want to (the latter is my guess). Overall, I would say that it's probably easier to transfer from regulatory to medical than vice-versa simply because the skills in medical affairs are a bit less specialized, the prevalence/applicability of the PharmD, and there being overall more positions open

 

[lord999]

• TLDR: get yourself into a hot therapeutic area (e.g. oncology) in a company with a lot of upcoming launches.

That's the best advice one-liner for a starting job in industry that is not technical. Absolutely get on a product that sells itself (Zyvox was that in my time), and use it to learn how to sell in easy situations, because I don't care how good you are, if the drug just doesn't sell, well, you won't keep a job. And the converse is true, even if you are seriously incompetent, competence largely can be obscured by a fantastic product.

Regarding transferable skills, I don't know many people who have transitioned out of regulatory strategy but I'm not sure if that's because they were unable or because they didn't want to (the latter is my guess). Overall, I would say that it's probably easier to transfer from regulatory to medical than vice-versa simply because the skills in medical affairs are a bit less specialized, the prevalence/applicability of the PharmD, and there being overall more positions open

It's more that they were too old, too isolated, and too one-dimensional and the winds changed. So, in RA, there's kind of a rotation implied that you go in government and industry. Any real long-termer in RA ends up spending some time at a different company or the government, or within the same company, spending time in different portfolios, and building coalitions of both contacts and knowledge. Those who do build those networks, usually make it, because when they inevitably get the pink slip, there's five people who'll call them up with an offer to their firm. Those who don't, become pariahs and because no one recommends them or that their experience doesn't make them special, there *must* be something wrong with them.

 

[wazoodog]

I would pick RA - especially if it's RA strategy. I haven't done RA but know many that do, and I've done Med Info.

RA is significantly harder to get into without previous experience, yet more in demand when you do have the experience.

Not only that, in a RA strategic role you're likely to acquire valuable business skills and experience earlier that will translate upwards and to other areas - program management, clinical development, product lifecycle management, negotiating with a variety of other departments leaders, etc. In Med Info, you might put together a dossier, be part of a pub planning or semi-peripheral support for commercialization. In RA, you might take part in successfully filing an NDA - it's visible at a higher level and a much more recognizable achievement.

That said, Med Info is likely to be a more cushy job compared to RA - it's less pressure. RA is highly visible, which means more pressure from leadership but also more recognition for accomplishments (and more promotions). You don't have the MD cap in RA like you see in Med Affairs (which Med Info is often a part of). RA departments usually wield a lot of influence (and budget) within a company - they're one of the functions directly tied to revenue, the lifeline of a company.

Also, Med Info can and does get outsourced - sometimes offshore. RA strategy gets outsourced too, but because it requires specialized familiarity with the FDA and US regulatory environment - it gets outsourced to consultancies within the US. That means eventually you can go work for these consultancies (or start your own). As someone mentioned, regulatory strategy is continuously evolving and the only way to be a competent regulatory professional it is by putting in the years of experience - it's a steep learning curve. On the other hand, many PharmD grads have what it takes to be a competent Med Info specialist in a matter of months to an year.

 

[greenteapanacea]

Thank you OP for posting this thread and everyone else for responding. I'm sure this has helped a lot of people leaning toward industry.

 

[Argentium]

Just wanted to make one point on the "medical affairs ceiling" because its important - this highly depends on the company.

A simple linkedin search of the number of pharmacists > Vice President in Medical Affairs will give you a great idea of a) whether the ceiling exists and b) may serve as a good proxy to how well the degree is respected within the organization.

As wazoo mentioned, there's no ceiling for reg - PharmD's occupy the highest perch in reg affairs in multiple big pharma/biotech companies which is saying a lot considering PharmD's are a relatively new degree to begin with

 

[wazoodog]

Would you happen to have more insight into RA strategy in particular?

As mentioned, regulatory strategy is becoming increasingly innovative and complex. Years ago, I think companies followed a more black or white conservative approach. To stay competitive, they've had to develop strategic approaches that explore the gray areas.

Making it all the way to a successful NDA filing is quite a long journey which a person will be fortunate to be a part of a handful of times in their career. Along the way there are a series of strategic successes from RA to get the company there. Those orphan drug designations and fast track designations you hear about in the news are all outcomes of an RA group's strategic plan. Pursuing second indications (which to go for first), second formulations, what kind of therapeutic role (like adjuvant) to pursue are all strategic moves. It involves regulatory risk assessments, an understanding of prior precedents and successsful negotiations both internally and with health agencies.

When a company heads into an FDA advisory committee meeting, RA strategy is really the architect of planning the approach and leading it. They're also a key party in health agency inspections.

A health agency wants too see more clinical data in safety in a specific patient population, or animal studies concerning a specific risk, or maybe pushing to see a biomarker which hasn't yet been identified? Maybe the NDA comes with post marketing commitments to run more kinds of studies within the first few years of approval. These are examples of things RA strategy respond to and often negotiate before, during and after. They also each represent additional time and money - how much more partly depends on the successful negotiations from RA. These are all complex problems a company needs seasoned regulatory professionals to navigate. The demand is so high because Regulatory competency takes years to build.

On the other hand, med info is essentially disseminating information to a customer, whether that be an HCP, consumer or internal stakeholder. A newly minted PharmD or even RN can learn how to do this pretty competently in months. Theres obviously more to being a seasoned MI professional, but point is it's easier to fill the position and Med Info is considered more of a commercial service.

To illustrate how versatile RA is, when the drug safety head position is vacant usually the RA head acts as the interim lead. RA is one of the first to be established in startups and one of the last to go when they fail.