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Actual Talent Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology. ¿Listo para inscribirse? Antes de hacerlo, asegúrese de leer todos los detalles pertenecientes a este trabajo en la descripción a continuación. Regulatory Operations Specialist We are seeking a Regulatory Operations Specialist to join one of our clients in the pharmaceutical sector. The position is based in Barcelona and offers a hybrid work model. As the Regulatory Operations Specialist, you will support our Regulatory Affairs department by contributing to the analysis and reporting of regulatory data. As part of the transition to a unified platform, this position will ensure consistent recording and use of regulatory data as well as the execution of reporting activities. The role reports to Corporate Head of Regulatory Affairs. Responsibilities Implementing our RIM & DMS project as per the agreed timelines in liaison with our chosen external provider. Contributing with IT team on RA projects requiring data analysis or data migration, as needed. Managing electronic document management systems to ensure compliance and accessibility of regulatory documents. Reviewing & assessing the integration of the local RA folders in each affiliate (local folders vs Corporate folders). Continuously monitoring and optimizing regulatory operations processes to improve efficiency and compliance. Ensuring compliance with the regulatory requirements related to our RA platforms & databases and providing regulatory intelligence to support strategic decision making (new HAs requirements). Proposing process/system improvements to better align/use data for RA activities. Establishing measures/KPIs to improve data quality, efficiency and compliance. Collaborating with relevant RA teams, quality and other departments to ensure alignment & compliance. Qualifications Bachelor's degree in a scientific or related field; 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 (eg eCTD) and regulatory submission software. Be a data-driven professional who thrives working with IT systems & databases. RIMS (Regulatory Information Management System) knowledge and Reporting tools are preferred. Fluent in English. #J-18808-Ljbffr
