Systems Operations Specialist - Regulatory Affairs

Antes de solicitar este puesto, por favor, lea la siguiente información sobre esta posibilidad que encontrará a continuación.
Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause

Neuraxpharm is looking for a Systems Operations Specialist - Regulatory Affairs based in Barcelona (hybrid role).

Your Mission
The Regulatory Operations Specialist ensures accurate and consistent regulatory data management, supporting analysis, standardization, and reporting to maintain compliance. The role also supports the transition to a unified regulatory data platform, ensuring harmonized data practices, data integrity, and effective coordination across Regulatory Affairs.

Your Major Accountabilities

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- Implement the RIM & DMS project on schedule, coordinating with the external provider,



and manage electronic document systems to ensure compliant and accessible regulatory records.
- Support RA and IT teams on projects involving data analysis, data migration, and system integrations, identifying discrepancies and aligning data across platforms.
- Maintain regulatory databases and platforms compliant with requirements (PLM, IDMP, XEVMPD), manage Pharmacopoeia updates (BP, EP, USP), and provide regulatory intelligence for decision-making.
- Review and harmonize local RA folders across affiliates, updating SOPs and proposing process/system improvements to enhance data quality, efficiency, and compliance (including KPIs).
- Collaborate with cross‑functional and global RA teams to ensure timely regulatory deliverables and operational alignment, while keeping the organization updated on changes in Agencies’ portals and relevant HA/EMA/CHMP webinars.

We Would Like You To Have

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- Basic Bachelor's degree in a scie

📌 Systems Operations Specialist (Sant Joan Despí)
🏢 Neuraxpharm
📍 Sant Joan Despí