Systems Operations Specialist - Regulatory Affairs

Actual Talent Spain; Barcelona; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

Actual Talent Spain partners with a Pharma Company to recruit a Systems Operations Specialist - Regulatory Affairs for its Barcelona team. The role centers on regulatory data management, data harmonization, and compliance across RA operations.

The incumbent will support the transition to a unified regulatory data platform, ensure data integrity, and coordinate with RA and IT teams on data migrations and system integrations, including eCTD submissions.

Formación

• Bachelor's degree in a scientific field.
• Experience in Regulatory Operations/Regulatory Affairs.
• 5–7 years in Regulatory Affairs or similar.
• Data-driven with IT systems and databases.
• Knowledge of Regulatory Information Management (RIM) and reporting tools preferred.
• Proficiency with electronic document management systems.

Responsabilidades

• Coordinate RIM and DMS implementations and ensure compliant regulatory records.
• Support data analysis, migration, and system integrations across RA/IT teams.
• Maintain regulatory databases (PLM, IDMP, XEVMPD) and keep up with pharmacopoeia updates.
• Harmonize local RA folders across affiliates and propose process improvements.
• Collaborate with global RA teams to meet regulatory deliverables and monitor agencies portals.

Conocimientos

Data management

RIM

Data analysis

IT systems

Educación

Bachelor's degree in science

Herramientas

eCTD

Descripción del empleo

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 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

• 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.
• Proficiency in electronic document management systems (eg eCTD) and regulatory submission software.