Experteer Overview
In this role you drive study start-up readiness and regulatory compliance across assigned studies. You will coordinate internal and external stakeholders to deliver milestones on time while ensuring quality and regulatory adherence. You shape regulatory strategy and SSU plans, and provide subject-matter expertise on documentation, submissions, and translations. You will lead country-specific activities, manage risks, and ensure alignment with ICH-GCP and local requirements. This is a hands-on, cross-functional role with a meaningful impact on study timelines and patient access.

Compensaciones / Incentivos
• Lead study start-up and regulatory activities for assigned countries or projects of medium complexity
• Prepare, review and quality check regulatory and SSU documentation (submissions, essential documents, translations) for completeness and compliance
• Draft, negotiate, finalize, and execute clinical site agreements and ancillary agreements within timelines
• Review documentation (labels, patient information sheets, diary cards, insurance)



for regulatory compliance
• Provide regulatory/SSU strategic input; develop regulatory strategy and SSU plan
• Escalate risks to the project team and support corrective and preventive actions
• Arrange for translation of essential documents as required
• Support development of core documents and operating procedures
• Coordinate with internal teams, clients, and external stakeholders to ensure milestones are met
• Perform other duties as assigned

Responsabilidades
• Regulatory affairs experience in clinical studies
• Experience leading SSU activities and submissions
• Ability to work in multi-country regulatory environments
• Knowledge of ICH-GCP and country-specific regulatory requirements
• Strong documentation and quality control skills
• Contract and site agreement management experience
• Translation coordination of essential documents

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