Head of Scientific Affairs, Quality & Regulatory Compliance (EU)

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Ena Biologics
ScreenedHybridFull Time
London, City of London
Posted 4 days ago
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About the role

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 following information provides an overview of the skills, qualities, and qualifications needed for this role.

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.


Why join us?

  • Build from the ground up – Play a central role in shaping our EU regulatory and quality infrastructure
  • High-impact role – Direct influence on product approvals, site activation, and market entry
  • Leadership exposure – Work closely with senior leadership and contribute to strategic decision-making
  • Ownership & autonomy – Take full responsibility for your domain with the freedom to implement your vision
  • Equity upside – Share in the company’s success through a meaningful equity package
  • Mission-driven – Help xwzovoh 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


Please send us a cover letter and your CV on

About this listing

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