Global Regulatory Lead - Late-Phase Biotech

Barrington James Limited; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

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.

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 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.

Skills

Regulatory Affairs

Clinical-stage development

Regulatory submissions

Health authority interactions

Regulatory operations

Vendor management

Project management

Stakeholder management

Lean biotech environment

Job description

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