Regulatory Radar – Hiring Regulatory Affairs talent in a changing market

Hayley has nearly a decade of experience specialising in Regulatory Affairs recruitment, earning a strong reputation for placing exceptional Regulatory Affairs and Quality Assurance professionals across the US life sciences industry, from Associate to Head of level. She partners predominantly with Phase II and III biotech organisations, typically with fewer than 200 employees, collaborating closely with senior leadership to develop hiring strategies, refine role requirements, and optimise recruitment processes that deliver efficient, high-quality hiring outcomes.

As we head towards Q4, the regulatory market continues to give us plenty to talk about.

Over the past month, we’ve seen further clarity around the future direction of FDA device reviews, continued regulatory activity across biotech and CMC, and another round of restructuring across the East Coast biotech market.

From a talent perspective, there’s a common thread running through much of this: companies may be keeping a close eye on headcount, but the need for specialist regulatory expertise hasn’t gone away.

Here’s what’s on my radar this month.

On the Radar: FDA Focus shifts to consistency and predictability

The proposed MDUFA VI programme continues to generate discussion across the medtech industry, and I think one point is particularly interesting.

There is a growing emphasis on making the review process more consistent and predictable, alongside supporting areas such as AI, digital health and innovative medical technologies. For medtech businesses, particularly smaller and growing organisations, predictability can be just as valuable as speed.

If regulatory teams have greater clarity around FDA expectations and interactions, businesses can plan development programmes, investment decisions and commercial timelines with more confidence.

It also reinforces the importance of strong regulatory strategy before a submission reaches the FDA – The ability to anticipate questions, engage effectively with the agency and build a clear regulatory pathway is becoming increasingly valuable.

What does this mean for talent?

I expect this to continue driving demand for Regulatory Affairs professionals with genuine FDA interaction experience.

There’s a big difference between having worked on an FDA submission and having personally led agency interactions, shaped submission strategy and challenged development teams on the regulatory pathway.

That distinction is becoming increasingly important when companies are hiring at Director and VP level.

Biotech Radar: CMC expertise moves further up the agenda

Another area that has caught my attention recently is the continued FDA activity around biologics, cell and gene therapy and pharmaceutical quality. Recent guidance activity has included areas such as container closure systems for drugs and biologics, alongside continued focus on development and submission expectations for advanced therapies.

It might not generate the same headlines as AI, but from a recruitment perspective Regulatory CMC is one of the areas I’ll be watching closely.

“For biotech companies approaching clinical or commercial milestones, manufacturing and CMC strategy can quickly become business-critical. The talent pool is relatively specialised – professionals who can combine strong Regulatory CMC expertise with experience across biologics, cell and gene therapy or other complex modalities are likely to remain highly sought after.”

As companies begin planning their 2027 regulatory milestones, I wouldn’t be surprised to see Regulatory CMC become one of the more competitive hiring areas heading into Q4.

East Coast Market Watch: Leaner teams, bigger expectations

The East Coast biotech market continues to demonstrate just how selective companies are becoming with investment and headcount.

Boston-based Aura Biosciences, for example, recently announced a 20% workforce reduction as it narrows its focus around ocular oncology. At the same time, the company reshaped its leadership team, including appointing new Regulatory and Quality leadership.

It’s an interesting example of something we’re seeing more broadly.

Reducing overall headcount doesn’t necessarily mean reducing investment in critical expertise.

When businesses narrow pipelines or extend cash runway, the remaining team often becomes more strategically important. For Regulatory Affairs, that can mean fewer people carrying broader responsibilities across strategy, submissions, Quality, external partners and executive communication.

This creates a very different hiring brief.

So, rather than simply asking: “Does this person have the right technical experience?”

Companies need to ask: “Can this person operate effectively in a lean organisation and make an impact beyond their immediate remit?”

Asking that second question can dramatically reduce the available candidate pool.

Talent Trends: The regulatory hiring market is becoming more specific

One thing I’m noticing is that Regulatory Affairs hiring is becoming increasingly skills-led rather than headcount-led. Businesses aren’t necessarily building large regulatory departments. Instead, they’re identifying gaps that could prevent them reaching the next milestone.

That might be:

• Someone with strong FDA interaction experience
• A Regulatory CMC specialist
• A leader who understands both US and global strategy
• Digital Health or SaMD expertise
• Combination Product experience
• Someone capable of building a regulatory function from scratch

This is also creating opportunities for regulatory consultancies; Where permanent headcount is difficult to justify, businesses still need the expertise. Specialist consultants and interim leaders can provide that capability around a specific submission, programme or milestone.

For consultancies, however, that creates its own recruitment challenge: the same specialists their clients need are often the hardest people for them to hire too.

My hiring forecast for 2026 Q4

As we approach Q4, here are three things I expect to see in the Regulatory Affairs hiring market.

• Regulatory CMC demand will increase

As biotech companies map out 2027 clinical and regulatory milestones, I expect experienced CMC professionals — particularly those working with complex biologics and advanced therapies — to become increasingly sought after.

• Companies will hire fewer people, but expect more from each hire

The era of building teams ahead of anticipated growth has changed for many smaller biotech organisations.

Hiring will remain targeted, and companies will increasingly favour professionals who can operate strategically whilst still being comfortable getting into the detail.

• Consultancy and fractional support will remain attractive

Where businesses need expertise but aren’t ready to commit to permanent headcount, regulatory consultancies, contractors and fractional leaders will continue to play an important role. That could make for an interesting talent battle between industry and consulting firms for experienced Regulatory Affairs professionals. The theme I keep coming back to this year is specialisation.

Regulatory teams may be getting leaner, but the challenges they’re dealing with aren’t getting any simpler. If anything, they’re becoming more complex.

Whether it’s FDA interactions, changing expectations around AI, CMC strategy or increasingly specialised development programmes, businesses need people with real depth of expertise who can also understand the wider commercial picture.

For hiring managers, that means being clear about what you actually need from a Regulatory Affairs hire, and for Regulatory professionals, it’s about showing where your specialist expertise adds value, rather than simply listing the submissions you’ve worked on.

As we head into autumn, I’ll be watching closely to see where businesses continue to invest, despite the wider pressure on biotech headcount.

Hayley Shayestehroo

Senior Consultant