Regulatory Affairs Specialist
Grifols Sant Cugat del Vallès
Experteer Overview
Join Grifols as Regulatory Affairs Specialist within Diagnostic Regulatory Affairs to drive submission and maintenance of product registrations and variations. You will coordinate technical-regulatory documentation, respond to Health Authority queries, and help maintain the Technical Dossier and department SOPs.This role supports global product approvals and quality compliance in a leading plasma-derived medicines company. You will work with cross-functional teams to enable timely registrations and renewals, contributing to Grifols’ mission to improve health worldwide.
Compensaciones / Beneficios- Prepare and submit registration, renewal, and variation dossiers for relevant products
- Provide official responses to Health Authority questions
- Evaluate, prepare, and follow up on technical-regulatory documentation
- Prepare and review supporting documentation and regulatory responses within timelines
- Maintain and update department procedures and SOPs within regulatory scope
- Update and maintain the Technical Dossier
- Bachelor in Health Sciences
- experience in Regulatory Affairs or technical departments within the pharmaceutical industry
- analytical skills, attention to detail, and ability to summarize and evaluate
- Advanced level of Spanish and English (C1) and proficiency in MS Office (Excel)
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