Experteer Overview
In this role you drive site initiation readiness and regulatory compliance for assigned studies. You will coordinate cross-functional activities and act as the regulatory subject matter expert for multi-country environments. You shape regulatory strategy, prepare and review essential documents, and ensure timely delivery of study start-up milestones. You will liaise with internal teams, clients, and external stakeholders to manage risk and maintain high quality, compliant submissions.

Compensaciones / Incentivos
• 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, including submissions, essential documents, and translations, ensuring compliance with ICH-GCP and country requirements
• Draft, negotiate, finalize, and execute clinical site and ancillary agreements and amendments at country or regional level within timelines
• Review regulatory documents (labels, patient information sheets, diary cards, insurance) for compliance with ICH-GCP and country-specific rules




• Provide regulatory/SSU strategic input; develop regulatory strategy, SSU plan, SOPs, and core documents
• Identify and escalate regulatory risks to the project team and support corrective actions
• Arrange for translation of essential documents as required
• Support the preparation and review of complex technical/scientific/legal documentation
• Collaborate with internal and external stakeholders to ensure alignment and delivery

Responsabilidades
• Regulatory affairs expertise in clinical studies, including multi-country environments
• Ability to draft, review, and negotiate regulatory and study start-up documents and agreements
• Strong knowledge of ICH-GCP and country-specific regulatory requirements
• Experience coordinating cross-functional teams and external stakeholders
• Risk management and issue escalation skills
• Ability to work independently within defined scope and make regulatory decisions

Requisitos principales
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📌 Specialist/Snr Specialist Study Start Up and Regulatory Affairs (Madrid)
🏢 Ergomed Group
📍 Madrid