Director of Regulatory Affairs and Compliance at lfb

The successful candidate will coordinate the preparation, drafting, and review of the Quality and Safety sections of the Master Plasma File (PMF), ensuring regulatory compliance and data reliability. This involves managing safety sections by collecting and analyzing epidemiological data, conducting risk assessments, and monitoring CAPA activities. The role also includes coordinating quality sections by gathering data from plasma suppliers and internal services, ensuring regulatory archiving, and translating data into PMF dossiers. Additional responsibilities involve regulatory monitoring, integrating PMF data into databases and ERP systems, handling change requests, preparing applications for plasma import authorizations, conducting impact analyses of regulatory developments, and providing operational support.