Systems Operations Specialist - Regulatory Affairs

Location

Barcelona (hybrid role)

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.

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 integral 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.

Required Qualifications

- 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.
- Proficiency in electronic document management systems (e.g. eCTD) and regulatory submission software.
- Data‑driven professional who thrives working with IT systems & databases.
- RIMS (Regulatory Information Management System) and reporting tools knowledge preferred.
- Excellent organizational, communication, and problem‑solving skills.
- Fluent in English and Spanish.

Benefits

Competitive remuneration and professional development opportunities within a leading European specialty pharmaceutical company.

Equal Employment Opportunity

Neuraxpharm is committed to an inclusive, diverse, safe, and respectful work environment, ensuring equal opportunity for all employees.

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📌 Systems Operations Specialist - Regulatory Affairs (Sant Joan Despí)
🏢 Neuraxpharm
📍 Sant Joan Despí