Experteer Overview
In this role, you will lead and coordinate study start-up and regulatory activities to achieve site initiation readiness. You will serve as a regulatory subject matter expert and liaison among internal teams, clients, and external stakeholders. You are responsible for delivering regulatory milestones within scope and timelines while ensuring compliance with ICH-GCP and country-specific requirements. You will shape regulatory strategy, SSU plans, and critical documents, while proactively managing risks and escalating issues as needed. This is an opportunity to influence multi-country start-up programs and drive compliant, timely delivery in a cross-functional setting.

Compensaciones / Ventajas
• Lead study start-up and regulatory activities for assigned countries or projects of medium complexity to meet timelines and quality standards
• Prepare, review, and QC regulatory and SSU documentation (submissions,



essential documents, translations) for completeness and compliance
• Draft, negotiate, finalize, and execute clinical site agreements and amendments per project needs and country regulations
• Review labels, patient information sheets, diary cards, insurance, and related materials for adherence to ICH-GCP and country-specific requirements
• Contribute to complex technical/scientific/legal documentation and coordinate translations as required
• Provide regulatory/SSU strategic input; develop regulatory strategy and SSU Plan, SOPs, and core documents
• Identify and escalate risks to protect deliverables and support CAPA actions
• Perform other duties as assigned

Responsabilidades
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Requisitos principales
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📌 Study Start Up and Regulatory Affairs Specialist (2 years plus experience) (Madrid)
🏢 Ergomed Group
📍 Madrid