Regulatory Radar – The value of a good FDA conversation

RAPS Convergence in Charlotte has given the regulatory community plenty to reflect on this month.

The discussions ranged from AI in drug development to the practicalities of meeting with health authorities. Meanwhile, September brought new FDA activity around non-animal testing methods and some significant regulatory updates from East Coast biotech companies. For me, the thread connecting these stories is the importance of knowing what evidence a regulator needs, and how to make the case for it.

Here’s what’s on my radar this month…

On the Radar: The value of a good FDA conversation

One of the most practical takeaways from Convergence came from a discussion with regulators about sponsor meetings. Their advice was straightforward: engage early, be transparent, support your questions with the right data and be prepared to listen to the response.

That sounds simple, but anyone who has been involved in a significant FDA interaction will know how much preparation sits behind it. A meeting can have real consequences for a development programme. The Regulatory lead needs to bring together the right people, understand where the evidence is strong or uncertain, and make sure the business is ready to act on the feedback it receives.

What does this mean for talent?

When a company says it wants someone with FDA experience, I think it’s worth being specific. Has that person supported a meeting, led the preparation, presented the company’s position or helped reshape the programme afterwards?

Those are different levels of experience, and the distinction matters most when a business is approaching a pivotal decision.

Biotech Radar: A wider conversation about nonclinical evidence

In September, FDA issued a direct final rule clarifying that non-animal methods can be used, where appropriate, to assess the safety of drugs and biologics before studies in humans. The methods it discusses include work with human cells, organs-on-chips and computer models. I wouldn’t read this as a sudden replacement for established testing approaches. What interests me is the question it raises for development teams: how do you decide which method is appropriate, and how do you demonstrate that the resulting evidence is reliable?

That calls for close work between Regulatory, nonclinical, scientific and clinical colleagues. As newer approaches develop, the ability to assess the evidence and explain it clearly to a health authority could become an increasingly valuable part of a Regulatory professional’s skill set.

East Coast Market Watch: Two very different regulatory milestones

Two September updates from Massachusetts show how varied the work can be for a biotech Regulatory team.

uniQure, which has a presence in Lexington, announced the submission of a US Biologics License Application for its investigational Huntington’s disease gene therapy. It also submitted a UK marketing authorisation application. These are major milestones, with substantial work still to come as the applications move through review.

Compass Therapeutics in Boston reported a different kind of development. Following FDA feedback, the agency recommended a trial demonstrating a survival benefit before Compass submits a BLA for tovecimig in advanced biliary tract cancer. Compass has said it intends to continue engaging with FDA as it prepares its submission.

Neither example tells us what these companies will do with headcount. They do, however, show why experienced Regulatory leadership matters at different points in a programme: both when an application is submitted and when agency feedback calls for difficult decisions.

Talent Trends: Being able to influence the decision

The hiring briefs I find most interesting are often the ones where the technical requirements are only part of the story.

A business may ask for BLA experience, FDA interaction experience or knowledge of an advanced therapy. The more useful question is what the person will need to do with that experience.

Will they need to challenge an evidence plan? Help leadership understand the implications of agency feedback? Bring Clinical, CMC and Quality colleagues together around a regulatory strategy?

For smaller biotech teams, these responsibilities can sit with a relatively small number of people. It makes hiring more specific, because the right candidate needs both technical depth and the confidence to influence decisions across the business.

My hiring forecast for 2026 Q4

As companies plan their next regulatory milestones, here are three areas I’ll be watching.

• FDA interaction experience will remain a strong differentiator

Particularly for senior hires, I expect businesses to look closely at what candidates personally owned in agency meetings and how they used the feedback afterwards.

• Evidence strategy will receive more attention

From advanced therapies to newer nonclinical methods, teams need people who can judge whether the evidence supports the pathway they want to pursue and identify gaps early.

• Hiring briefs will become more precise

Smaller organisations may have little room for a hire who covers only one narrow part of the role. I expect more emphasis on specialists who can work across functions and contribute to the decisions behind a submission.

The thought I’ve taken from this month’s developments is that Regulatory expertise is often most valuable before a document reaches an agency.

It’s there in the questions a team asks, the evidence it chooses to generate and its willingness to change course when the feedback calls for it.

“For those working in Regulatory Affairs, what experience has made the biggest difference when your team has faced a difficult development decision?”

Looking to hire in the regualtory 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