Leadership

Interim Leadership

This is a strategic leadership service for companies that need senior regulatory direction without hiring a full-time Head of Regulatory. PrimeRA can operate as a fractional Head of Regulatory Affairs - or equivalent level - depending on what the company needs at that point in time, providing end-to-end regulatory direction across US, UK and EU contexts as needed.

Who This Is For
Any stage, any structure

Senior regulatory leadership, to support your programme

Companies at any stage engage this service - from academic spinouts, early-stage biotech and ATMP companies without a regulatory function in place, to more mature organisations that need an independent senior presence alongside existing resource.

Academic spinouts, early-stage biotech and ATMP companies building their first senior regulatory capability
More mature organisations that need senior oversight, external challenge or interim cover
Teams with existing regulatory contributors who need clearer senior direction and alignment
Companies navigating pivotal decisions across US, UK and EU development pathways
How We Work With Your Team
Partnership-led

An embedded leadership role

PrimeRA works from inside the organisation. The Interim Leader can participate in and, where appropriate, lead internal team meetings, sit on governance or development committees, and report directly into the C-suite. The degree of involvement is shaped around what the company needs.

Our role is to pressure-test regulatory plans, sharpen agency positions and align technical and executive stakeholders.

Coordinates clinical, CMC, technical and executive stakeholders around one regulatory position
Assesses programme and portfolio decisions with a senior regulatory lens
Shapes agency interaction strategy across FDA, EMA and MHRA contexts
Brings independent judgement while operating as a trusted internal leadership presence
Able to scale support through the wider PrimeRA team when programmes get busier - without losing the continuity of the leadership relationship

For example, PrimeRA's Interim Leadership has included serving Head of Regulatory for a European ATMP company, providing C-suite level regulatory leadership while internal capability was being built.

Why PrimeRA

Interim Leadership tailored to your programme

01
Senior regulatory judgement when it matters most

PrimeRA brings the level of strategy needed when programme decisions carry real downstream consequences for development path, agency positioning and portfolio risk.

02
Embedded, not at arm's length

We work inside the business, contribute to decision-making forums and help align the organisation around a clear regulatory position. Companies gain the experience and integration of a senior hire wihtin a cost-effective, scalable structure.

03
Leadership shapes execution across regulatory strategy and CMC

PrimeRA's Interim Leadership focuses on direction, oversight and challenge. Our partners bring many years of hands-on global regulatory strategy and CMC leadership experience. Document writing and full execution sit under Delivery - while Interim Leadership shapes the strategy.

What Is In Scope

Leadership, challenge and oversight

The scope of Interim Leadership focuses on leadership, decision-making, challenge and oversight. Full execution of regulatory documents are handled under the Delivery pillar.

✓  In scope
Senior regulatory leadership at fractional Head of Regulatory Affairs or equivalent level
End-to-end regulatory direction across US, UK and EU contexts as needed
Stress-testing programmes, portfolios and major development decisions
Challenge and oversight of study design choices and risk–benefit narratives
Strategic direction for FDA, EMA and MHRA interactions and meeting preparation
Internal stakeholder alignment, governance participation and C-suite reporting
→  Sits under Delivery
Hands-on writing of regulatory documents - see Delivery
Authoring full submission packages (IND, CTA, IMPD, MAA, BLA) - see Delivery
End-to-end dossier drafting and compilation - see Delivery
Standalone document production without a leadership oversight context - see Delivery
Project management of submission timelines and author coordination - see Delivery
FAQs

Common questions

Interim Leadership is designed to operate as an embedded senior leadership role inside the company. The focus is on decision-making, direction, challenge, oversight and internal alignment, at the level you would expect from a Head of Regulatory. The engagement is shaped around the company's needs, not structured around fixed scopes of advice.
Yes - and it is specifically designed for this situation. Many companies already have internal regulatory contributors but still need a senior leader to set direction, challenge thinking, prioritise activity and provide executive-level regulatory judgement. Interim Leadership is designed to complement and strengthen existing internal capability, not replace it.
No. The scope focuses on leadership, decision-making, challenge and oversight. Writing, authoring and full execution of regulatory documents sit under the Delivery pillar. That said, Interim Leadership will strongly shape the position, framing, structure and strategy that guides all of that work - meaning the two pillars are closely connected in practice.
Yes. The model is intentionally embedded. Depending on what the organisation needs, the Interim Leader can participate in and lead internal meetings, sit on governance or development committees, and report directly into the C-suite. The structure is always shaped around the company rather than a fixed framework.
Yes. Interim Leadership can provide end-to-end regulatory direction across US, UK and EU contexts as needed. PrimeRA has experience across all three regulatory environments, and the Interim Leadership role is designed around the company's overall development strategy rather than any single jurisdiction.
No. The emphasis is on flexibility around the company's needs. Our Leadership packages are scoped on a case-by-case basis to ensure the right fit and level of input. This can evolve as the organisation and its regulatory situation develops.

PrimeRA · Interim Leadership

Need senior regulatory leadership inside the business?

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