Systems Operations Specialist – Regulatory Affairs

Winid is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.

Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.

About the client:

A pharmaceutical company focused on the Central Nervous System (CNS) area is looking for professionals who want to make a difference and contribute to improving patients’ lives.

Being part of this team means working with a strong purpose-driven mission in a highly specialized healthcare environment.

The company is seeking a Systems Operations Specialist – Regulatory Affairs based in Barcelona (hybrid role).

Job description:

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.

• 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 Regulatory Affairs and IT teams in 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 Regulatory Affairs folders across affiliates, update SOPs, and propose process/system improvements to enhance data quality, efficiency, and compliance (including KPIs).

• Collaborate with cross-functional and global Regulatory Affairs teams to ensure timely deliverables and operational alignment, and stay updated on changes in agencies’ portals and relevant HA/EMA/CHMP updates and webinars.

Requirements:

• Bachelor’s degree in a scientific or related field (advanced degree preferred).

• Background in pharmaceutical companies in a similar Regulatory Operations role.

• 5–7 years of experience in Regulatory Affairs.

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

• Strong data-driven mindset, comfortable working with IT systems and databases.

• Knowledge of RIMS (Regulatory Information Management Systems) and reporting tools is a plus.

• Excellent organizational, communication, and problem-solving skills.

• Fluent in English and Spanish.