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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 / Ventajas

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- 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 elevate 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

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- 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
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- 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

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a Regulatory Submissions Coordinator to join our Clinical Operations team in Spain.This position ...

Misión del Puesto

Te vas a encargar de diseñar, implementar el ciclo de vida de los productos que forman parte del catálogo comercial del Grupo Gigas, así como de identificar en el mercado junto c...

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