About the client:

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We are partnering with a Pharma Company with a strong international presence and an ambitious growth strategy. Operating in a complex and highly regulated environment, the company is currently seeking a

Systems Operations Specialist - Regulatory Affairs

to join its team in Barcelona.

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

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 general 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

Basic Bachelor's degree in a scientific or related field; advanced degree preferred.
Background in

Pharmaceutical Companies

in a similar Regulatory Operations role.
Minimum of 5 t

📌 Systems Operations Specialist (Barcelona)
🏢 Actual Talent Spain
📍 Barcelona