Senior Regulatory Affairs Manager

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.