Systems Operations Specialist - Regulatory Affairs
hace 5 días
Sant Joan Despí
ppbSystems Operations Specialist - Regulatory Affairs /b /p h3Location /h3 pBarcelona (hybrid role) /p h3Your Mission /h3 pThe 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. /p h3Major Accountabilities /h3 ul liImplement the RIM DMS project on schedule, coordinating with the external provider, and manage electronic document systems to ensure compliant and accessible regulatory records. /li liSupport RA and IT teams on projects involving data analysis, data migration, and system integrations, identifying discrepancies and aligning data across platforms. /li liMaintain regulatory databases and platforms compliant with requirements (PLM, IDMP, XEVMPD), manage Pharmacopoeia updates (BP, EP, USP), and provide regulatory intelligence for decision‑making. /li liReview and harmonize local RA folders across affiliates, updating SOPs and proposing process/system improvements to enhance data quality, efficiency, and compliance (including KPIs). /li liCollaborate 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. /li /ul h3Required Qualifications /h3 ul liBasic Bachelor’s degree in a scientific or related field; advanced degree preferred. /li liBackground in Pharmaceutical Companies in a similar Regulatory Operations role. /li liMinimum of 5 to 7 years of experience in Regulatory Affairs. /li liProficiency in electronic document management systems (e.g. eCTD) and regulatory submission software. /li liData‑driven professional who thrives working with IT systems databases. /li liRIMS (Regulatory Information Management System) and reporting tools knowledge preferred. /li liExcellent organizational, communication, and problem‑solving skills. /li liFluent in English and Spanish. /li /ul h3Benefits /h3 pCompetitive remuneration and professional development opportunities within a leading European specialty pharmaceutical company. /p h3Equal Employment Opportunity /h3 pNeuraxpharm is committed to an inclusive, diverse, safe, and respectful work environment, ensuring equal opportunity for all employees. /p /p #J-18808-Ljbffr