About the job

I’m supporting a UK-based clinical-stage biotechnology company with the appointment of a Senior Manager, Regulatory Affairs.

This is a senior, hands-on regulatory role supporting a development programme as it progresses into late-phase clinical development.

The position will play a key role in shaping and executing global regulatory strategy across major markets, including the FDA, EMA, MHRA, Health Canada and TGA, while working closely with senior internal stakeholders and external regulatory partners.

Key Responsibilities Will Include

Supporting global regulatory and development strategy
Leading and supporting health authority interactions
Preparing and reviewing briefing packages, submissions and agency responses
Managing regulatory planning, commitments and key milestones
Overseeing CROs, consultants and external regulatory service providers
Supporting regulatory and inspection readiness
Developing and improving regulatory processes, SOPs and governance
Providing regulatory input into cross-functional development plans and key programme decisions
Supporting and managing members of the Regulatory Affairs team

What We Are Looking For

Significant Regulatory Affairs experience within pharma or biotech
Strong experience supporting clinical-stage and late-phase development programmes
Hands-on experience with regulatory submissions and health authority interactions
Experience working with FDA, EMA, MHRA or other major international agencies
Strong regulatory operations and project management capability
Experience working within an outsourced or virtual biotech model
CRO and external vendor management experience
Strong cross-functional stakeholder management
A pragmatic, commercially aware and hands-on approach

Experience operating within a lean, fast-paced biotechnology environment would be particularly relevant.

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Responsibilities