We are seeking an experienced and hands-on Head of Scientific Affairs, Quality & Regulatory Compliance (EU) to lead our European regulatory strategy, quality systems, and scientific oversight. This is a pivotal leadership role responsible for driving EMA interactions, establishing an inspection-ready EU GMP quality framework, and enabling successful product approvals and market entry. This role also requires strong knowledge of and previous experience in Quality Control (QC), including analytical methods, compliance with EU GMP standards, and alignment with regulatory expectations.
The ideal candidate brings deep expertise in EU regulatory pathways, biologics development (with a strong emphasis on biosimilars), and quality systems implementation. You will combine strategic leadership with operational execution, working cross- functionally and with external partners to ensure compliance, readiness, and delivery across all stages of
Build from the ground up – Play a central role in shaping our EU regulatory and quality infrastructure
Mission-driven – Help expand access to critical biologic therapies across Europe
Agile environment – Join a focused, collaborative team that moves quickly and values execution
Location: UK (Hybrid)
Hours: Full-time
Contract Type: Permanent
Reporting To: General Manager, UK
Compensation: Competitive salary and meaningful equity/share option
The ideal candidate brings deep expertise in EU regulatory pathways, biologics development (with a strong emphasis on biosimilars), and quality systems implementation. You will combine strategic leadership with operational execution, working cross- functionally and with external partners to ensure compliance, readiness, and delivery across all stages of
Build from the ground up – Play a central role in shaping our EU regulatory and quality infrastructure
Mission-driven – Help expand access to critical biologic therapies across Europe
Agile environment – Join a focused, collaborative team that moves quickly and values execution
Location: UK (Hybrid)
Hours: Full-time
Contract Type: Permanent
Reporting To: General Manager, UK
Compensation: Competitive salary and meaningful equity/share option
