The Regulatory Affairs Hiring Mistake We Keep Making: Are We Hiring for Yesterday’s Job?

There is a hiring habit in the pharmaceutical industry that, at first glance, makes perfect sense. We write a job description. We list the experience we need. We describe the products, markets, regulations, submissions, systems and responsibilities. Then we look for someone who has already done all of those things.

Ideally, we find someone who has done them for five years, in the same therapeutic area, in the same markets, using the same systems, and preferably with exactly the same responsibilities.

Perfect.

The problem is that we may have just found someone who is exceptionally well qualified to do the job we had yesterday. And that raises an interesting question: if we hire someone because they have already done exactly the same job somewhere else, why would we expect them to bring something different to the table?

The perfect match might not be the perfect hire

When hiring for Regulatory Affairs, it is very tempting to look for the "perfect match." We see a candidate who has managed exactly the same type of submissions, worked with the same health authorities, handled similar products and spent years in a comparable organization. The CV almost seems to have been written specifically for our vacancy.

It feels reassuring.

But Regulatory Affairs is not exactly known for staying still long enough for that plan to work perfectly. Regulations change. Health authority expectations evolve. Companies change their strategies. Products move into new markets. Development plans change. And occasionally, we face a problem where nobody has a nice PowerPoint explaining exactly what to do.

That is where things get interesting. Because the value of a regulatory professional is not only in knowing the answer. It is also in knowing how to find the answer when nobody has given it to you before.

Experience matters. But what do we do with it?

This is not an argument against experience. Experience is hugely valuable in Regulatory Affairs. But experience can be used in two different ways: to repeat what we have done before, or as a foundation for solving something new. The second one is what matters when we hire for the future.

Imagine two candidates. One has spent the last five years performing almost exactly the responsibilities described in our job advertisement. The other has a somewhat less obvious background. They have worked across different products, markets or organizational structures, changed roles, taken on unfamiliar problems and had to figure things out without a precedent sitting neatly in a shared folder.

Which one is better?

There is no universal answer, of course. But if we are hiring for the next three, five or ten years, perhaps we should spend less time asking who can reproduce the past and more time understanding who can deal with the future.

A job description describes what we need today. But the person we hire will eventually face something that wasn't in it. Suddenly, that beautifully constructed job description is looking a little optimistic. This is why problem-solving and adaptability should be core skills in Regulatory Affairs, not simply nice additions at the bottom of a vacancy.

Instead of only asking, "Have you done this before?", perhaps we should ask:

"Tell us about something you had to solve that you had never dealt with before."

How did they approach it? What did they learn? Who did they involve? What assumptions did they challenge? Those answers can tell us much more about how someone will perform in an unfamiliar situation.

And why would the best candidate want the same job twice?

There is another part of this conversation worth considering. Why would a strong Regulatory Affairs professional leave a company to do exactly the same thing somewhere else?

People move for many reasons, of course. But experienced professionals often want their next role to be a new challenge. They want to learn something new, work on different products or markets, take on broader responsibility, solve more complex problems or simply build something. So if our recruitment process is essentially saying, "We are looking for someone who has already done exactly what we need," we may unintentionally make the role less attractive to precisely the people who could bring something different.

The same applies across the pharmaceutical industry. Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Manufacturing, Market Access and Commercial all face situations that cannot simply be solved by repeating what worked last time. The industry needs people who can take what they know and apply it when the situation is different.

Because sooner or later, it will be different.

So perhaps we should change the question

When we recruit our next Regulatory Affairs professional, technical experience should absolutely matter. But alongside it, perhaps we should ask something more important: What happens when this person encounters something they have never seen before? Do they wait for someone to give them the answer? Or do they start asking questions, gathering information, connecting the dots and finding a way forward? Because that is the person we will eventually need.

Not when everything goes according to plan. When it doesn't. And in the pharmaceutical industry, we probably don't need to be reminded that "when it doesn't" is not exactly a rare scenario. Perhaps the best candidate isn't the person who matches 100% of the job description. Perhaps it is the person who has demonstrated that, when the job inevitably changes, they will be able to change with it.

That is the kind of experience worth hiring for.