Senior Regulatory Affairs Manager

Barrington James Limited; Greater London; Sur place; GBP 90 000 - 130 000; Plein temps

Résumé du poste

Barrington James Limited is supporting a UK-based clinical-stage biotechnology company by appointing a Senior Manager, Regulatory Affairs. The role is hands-on and focuses on guiding regulatory strategy across major markets, including FDA, EMA, MHRA, Health Canada and TGA, while partnering with senior internal teams and external partners.

Ideal candidates will bring significant Regulatory Affairs experience in pharma or biotech and a proven track record in late-phase development, regulatory

Qualifications

• Significant Regulatory Affairs experience within pharma or biotech.
• Hands-on experience with regulatory submissions and health authority interactions.
• Experience with FDA, EMA, MHRA or other major international agencies.
• Experience working within outsourced or virtual biotech models.

Responsabilités

• 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 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.

Connaissances

Regulatory Affairs

Clinical-stage development

Regulatory submissions

Health authority interactions

Regulatory operations

Vendor management

Project management

Stakeholder management

Lean biotech environment

Description du poste

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

• 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.