Life Sciences · Head of Regulatory Affairs
Head of Regulatory Affairs recruitment.
Retained regulatory leadership search for biotech, pharmaceutical and medtech companies.
What the role is
A short definition.
A Head of Regulatory Affairs leads the regulatory function — pathway selection, agency interactions, submission strategy, post-approval regulatory maintenance and (in medtech) CE / UKCA / FDA device pathways. The role sits between clinical development and commercial operations, and in smaller companies is often the CMO-adjacent second most senior scientific voice.
Core responsibilities
What we assess candidates against.
- Regulatory pathway strategy — MHRA, EMA, FDA and (for medtech) UKCA / CE / MDR
- Agency interactions — pre-submission meetings, briefing books, response strategy
- Submission strategy and execution — INDs, CTAs, NDAs, BLAs, MAAs, 510(k)s, PMAs
- Post-approval regulatory maintenance and lifecycle management
- Cross-functional coordination with Clinical Development, Medical Affairs, Quality and Manufacturing
- Investor and Board briefings on regulatory pathway risks and status
When to run this search
Typical triggers.
On entry into pivotal trials; ahead of a first regulatory submission; on a change of pathway or geography; on the transition from clinical development to post-approval regulatory maintenance; on the departure of an incumbent.
How we search
The specific approach we take.
Retained. Candidate pools include sitting Heads of Regulatory at comparable-stage companies, senior regulatory leaders from big pharma moving into biotech, and former agency staff moving into industry. Every mandate is led by a partner with regulatory pathway fluency.
FAQ
Frequently asked questions
Do you understand the difference between clinical-stage and commercial-stage regulatory leadership?
Yes. The profile changes materially — clinical-stage regulatory leaders focus on trial submissions and agency interactions, commercial-stage leaders focus on lifecycle management and post-approval submissions.
Can you support medtech regulatory searches with UKCA / CE / FDA experience?
Yes. Medtech regulatory searches are a distinct specialism — pathway experience does not transfer straightforwardly from pharma.
How do you handle candidates moving from big pharma to biotech?
This is a common but non-trivial transition. We assess candidates specifically for whether they can operate without the resource base of big pharma, and we calibrate the brief accordingly.
How long does a Head of Regulatory search take?
Twelve to sixteen weeks brief to accepted offer is typical.
How is compensation structured?
Base salary, cash bonus, and share-based long-term component. Senior regulatory leaders with successful submission track records now command a premium over general biotech benchmarks.
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