Regulatory Data Operations Specialist (RIM/RA)

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

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.