Opportunity
Head of Scientific Affairs, Quality & Regulatory Compliance (EU)
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
development and manufacturing.
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Why join us?
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Build from the ground up – Play a central role in shaping our EU regulatory and quality infrastructure
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High-impact role – Directly influence product approvals, site activation, and market entry
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Leadership exposure – Work closely with senior leadership and contribute to strategic decision-making
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Ownership & autonomy – Take full responsibility for your domain, with the freedom to implement your vision
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Equity upside – Share in the company’s success through a meaningful equity package
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Mission-driven – Help expand access to critical biologic therapies across Europe
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Agile environment – Join a focused, collaborative team
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Location: UK (Hybrid)
Hours: Full-time
Contract Type: Permanent
Reporting To: General Manager, UK
Compensation: Competitive salary and meaningful equity/share option
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