Head of Scientific Affairs

Head of Scientific Affairs focuses on 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 scientifi.

What the role involves

• 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 scientifi.
• Combine strategic leadership with operational execution, working cross- functionally and with external partners to ensure compliance, readiness, and delivery across all stages of.

Skills and requirements

• 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.

Confirmed role details

• 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.

Additional role context

• 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.
• The ideal candidate brings deep expertise in EU regulatory pathways, biologics development (with a strong emphasis on biosimilars), and quality systems implementation.
• Join a focused, collaborative team that moves quickly and values execution.