About the client:

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 to 7 years of experience in Regulatory Affairs.
- Be a data-driven professional who thrives working with IT systems & databases.
- RIMS (Regulatory Information Management System) knowledge and Reporting tools are preferred.
- Excellent organizational, communication, and problem-solving skills.

Indispensable

- Proficiency in electronic document management systems (eg eCTD) and regulatory submission software.
- Regulatory publishing

Languages

- Fluent English and Spanish.

📌 Systems Operations Specialist - Regulatory Affairs (Cataluña)
🏢 Actual Talent Spain
📍 Cataluña