Regulatory Radar – Earlier development needs the right expertise

As companies begin firming up their plans for 2027, I’ve been looking at what recent regulatory developments could mean for the teams delivering those plans.

There’s activity at both ends of the development process: FDA is testing approaches to help sponsors reach first-in-human trials more efficiently, while new guidance addresses manufacturing changes after a biosimilar has been approved.

We’ve also seen encouraging late-stage data from Massachusetts-based Disc Medicine, with an FDA resubmission planned before year-end.

From a talent perspective, these stories raise a useful question: does the expertise in your team match the next stage of your programme?

On the Radar: Earlier development needs the right expertise

FDA’s Expedited IND Pilot is testing a more collaborative approach to preparing for first-in-human studies.

Launched in September, the pilot pairs sponsors with qualified research institutions and allows FDA to review individual IND components as they are completed. It also encourages coordination around activities such as ethics review and clinical trial site activation. FDA retains responsibility for deciding whether a study can proceed.

What interests me is the practical challenge behind this.

Earlier review could help identify issues sooner, but sponsors still need people who can bring together the scientific, clinical and manufacturing information, identify gaps and keep the different contributors working towards the same plan.

What does this mean for talent?

For an early-stage biotech, the first Regulatory hire can have a significant influence on how the programme develops.

Someone who has maintained established submissions may bring different experience from someone who has helped a small company prepare its first IND. Both are valuable, but the hiring brief needs to reflect the work ahead.

Biotech Radar: The regulatory work continues after approval

In October, FDA issued final guidance on post-approval manufacturing changes for biosimilar and interchangeable biosimilar products, finalising a draft published in 2024.

Although this guidance addresses a specific group of products, it prompted a wider thought about how companies plan their Regulatory capability.

Getting an application submitted or approved is a major achievement. There is then a different set of responsibilities around maintaining the product and managing changes throughout its lifecycle.

For businesses approaching commercialisation, it’s worth asking how much experience their team has beyond the initial approval.

What does this mean for talent?

Regulatory CMC experience can cover quite different work. Early development, initial marketing applications and post-approval change management each bring their own challenges.

When a business asks for “strong CMC experience”, being clear about which of those it needs can make the search much more effective.

East Coast Market Watch: Disc Medicine prepares for its next submission

Watertown-based Disc Medicine announced in October that its Phase III APOLLO trial of bitopertin met all primary and secondary endpoints in erythropoietic protoporphyria, a rare condition associated with painful sensitivity to light.

The company plans to resubmit its New Drug Application by the end of 2026 and anticipates an FDA decision by mid-2027. Those remain the company’s planned timelines.

It’s an encouraging development for the programme and the patient community.

For me, it also illustrates why a positive clinical readout is such an important point for workforce planning. Teams need to translate the results into a regulatory submission while preparing for the questions and responsibilities that could follow.

That can involve Regulatory strategy, medical writing, CMC, Quality and potential launch preparation. Each needs clear ownership and enough capacity to deliver.

Talent Trends: Keeping the knowledge already in the team

Alongside hiring, I think retention deserves more attention as businesses plan for next year.

In a small Regulatory function, an experienced employee can hold a substantial amount of programme knowledge: why an approach was chosen, what an agency previously challenged and which questions remain unresolved.

When that person leaves, replacing their technical skills is only part of the task.

For leaders, this makes development opportunities, manageable workloads and clear responsibilities worth discussing before someone starts looking elsewhere.

It also makes succession planning and knowledge sharing practical business priorities, even in teams that are too small to have an obvious successor for every role.

My hiring forecast for the end of 2026 and into 2027

Here are three areas I’ll be watching.

• More distinction between development and commercial experience

I expect hiring managers to look more closely at the stage of a candidate’s experience, particularly when a business is preparing for its first marketing application or potential approval.

• Medical writing capacity will feature earlier in submission planning

Where major deliverables are approaching, I expect more discussion about who will author, review and coordinate the documents, and how much permanent or external support is needed.

• Retention will become part of the capability discussion

Before adding headcount, businesses should understand where they depend heavily on one person and what would happen if that expertise became unavailable.

The question I keep coming back to is whether companies are planning their people requirements far enough ahead.

A milestone may still be months away, but the work supporting it often starts much earlier. Having a clear view of the expertise already available, the gaps to fill and the people you need to retain can make that preparation far more manageable.

As you plan for 2027, where do you see the biggest challenge: finding specialist expertise, creating enough capacity or retaining the people already in your team?

Looking to hire in the regulatory affairs space?

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.

Hayley Shayestehroo

Senior Consultant