Systems Operations Specialist – Regulatory Affairs
Hybrid · Barcelona, Catalonia, Spain
Job Summary
Regulatory Operations Specialist – Regulatory Affairs in Barcelona (hybrid) supports accurate regulatory data management, analysis, standardization and reporting to maintain compliance. Responsibilities include implementing the RIM & DMS project with external providers, managing electronic document systems for compliant regulatory records, data migration and system integrations, harmonizing local regulatory folders, updating SOPs, and providing regulatory intelligence. Requires aBachelor’s degree in a scientific or related field, 5–7 years in Regulatory Affairs, proficiency with eCTD and regulatory submission tools, and fluency in English and Spanish. Collaboration with Global Regulatory Affairs, IT and cross-functional teams to ensure timely deliverables and ongoing compliance is essential.
Required Qualifications
- Bachelor’s degree in a scientific or related field (advanced degree preferred)
- 5–7 years of experience in Regulatory Affairs
- Proficiency in electronic document management systems (e.g. eCTD) and regulatory submission software
- Fluent in English and Spanish
- Strong data-driven mindset, comfortable working with IT systems and databases
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