Regulatory Affairs in small pharma and biotech: when being “senior” doesn’t mean someone is the right fit for the role

There is something we keep seeing in small pharma and biotech, especially in Regulatory Affairs, that deserves more attention: a large number of openings for Associate Directors, Directors and Senior Directors, while important work still seems to remain uncovered.

At first, this looks like a shortage of senior regulatory professionals. But perhaps the real shortage is slightly different: We are struggling to find people who are senior enough to lead, but still hands-on enough to do the work themselves.

This is not about saying that people coming from Big Pharma are not capable. Many regulatory professionals have built their careers there, and that experience is extremely valuable. Large pharmaceutical companies have complex products, global organizations and highly sophisticated regulatory systems. Working successfully in that environment requires a lot of knowledge and judgment.

The issue is that the operating model is different and the same title can mean a very different job in a small pharma or biotech.

Same title, very different reality

A Regulatory Director in Big Pharma may spend much of their time setting strategy, coordinating functions, managing governance, reviewing deliverables and overseeing external partners. That is a demanding role, and it makes sense in an organization where there are specialists, established processes and several layers of support around each function.

In a 50- or 100-person biotech, however, the same Director may need to develop the regulatory strategy, prepare the briefing package, work directly with the health authority, review submissions, challenge the CRO, understand the clinical and CMC implications, solve unexpected problems and build processes that simply do not exist yet. There are fewer people around them, fewer established systems and usually much less room to delegate.

The title is the same. The job isn't.

This is why we think the way we assess seniority sometimes needs to change. So, what does being “senior” actually mean? One of the most important questions we can ask in a biotech interview is actually very simple: “What did you actually do yourself?” Not what did your team do. Not what did the company achieve. Not what did you oversee.

What did you personally decide, write, build, solve or deliver? What did you do when there was no established process? What happened when the CRO was not delivering? What did you do when you had a regulatory problem but no internal expert to call? How much of the work could you have done yourself if you had needed to?

These questions are important because there is a significant difference between being accountable for a function and being able to execute that function. Someone can be an excellent leader of a large regulatory organization and still find it difficult to operate in a much smaller environment where there is no regulatory operations team, no large submission group and no specialist for every individual task.

That doesn't make them less senior. It means that their experience was developed in a different operating model. The problem comes when we hire for one operating model and expect performance in another.

And then the loop begins

A small biotech needs someone who can work independently across several areas. It hires an experienced person, often with a strong Big Pharma background, because that experience is a natural and understandable signal of seniority.

The person arrives and brings the operating model they know: coordinate, delegate, establish processes, manage stakeholders and use external expertise. Again, there is nothing inherently wrong with any of this. In fact, these are important skills.

But eventually, the amount of work is greater than what can realistically be covered through coordination alone. So more support is requested. A consultant is brought in. Then perhaps a contractor. Then another employee.

When the work is still there, the conclusion is often that the organization simply needs more capacity: “We need more people.”

So another Director or Associate Director is hired, frequently with a very similar profile and often from the same type of organization. And the cycle starts again. We add headcount, seniority and coordination, but some of the actual work remains uncovered. We fill the position without necessarily solving the problem.

Why this can become expensive very quickly

There is another side to this that is easy to overlook.

In a small biotech, every additional person changes the organization. More people mean more interfaces, more meetings, more handovers and more coordination. If the new hire is primarily a coordinator, the organization may gain management capacity without gaining the execution capacity it originally needed.

The company can then become surprisingly large without becoming proportionally more productive.

And because much of the remaining work can be outsourced, the problem can stay hidden. A CRO can perform the activity, a consultant can prepare the document, and an external specialist can provide the advice. All of these can be perfectly sensible decisions, but someone inside the company still needs enough expertise to understand the work, challenge what is being delivered and ultimately own the outcome. That internal person is critical.

What small pharma and biotech may really need

Perhaps the scarce profile is what we could call the one-person orchestra.

Not someone who literally does everything, but someone with deep expertise who can move comfortably between strategy and execution. Someone who can lead the regulatory strategy but also get into the details; manage a CRO but know enough to challenge the CRO; speak to the health authority, understand the clinical and CMC implications, and explain the consequences to senior management.

In other words, someone who can own the outcome without needing a large organization around them. And this is not unique to Regulatory Affairs. We see the same dynamic in Clinical Development, CMC, Quality, Medical Affairs, Operations and other functions.

As biotech becomes leaner and more focused on capital efficiency, individual leverage becomes increasingly important. The companies that need fewer people around each decision will naturally value people who can connect several disciplines and execute across boundaries.

That doesn't mean Big Pharma experience becomes irrelevant. Far from it. It means we should probably become more precise about which part of that experience is relevant to the job we are actually hiring for.

Perhaps the question should therefore be less:

“How senior is this person?”

and more:

“What can this person actually do when there is nobody else around to do it?”

Because in a small biotech, being “senior” may not mean managing more people, owning a larger budget or sitting further away from the details. It may mean being able to take a complex problem, get your hands dirty, and get it done.