Senior Regulatory Affairs Manager
hace 2 semanas
Job Title: Senior Manager, Regulatory Labelling Location: Spain, -Fully Remote Employee Type: Permanent As a Senior Manager, Regulatory Labelling you will take leadership on everything related to Regulatory Labelling. This includes inputting from a regulatory labelling perspective on developing and established drug programs and being accountable for driving global labelling strategies. Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents. Act as operational expert for the Global Labeling tracking in RIMs, ensure development and maintenance of templates, collaboration features and system upgrades. Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation. Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets. Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed. for labeling distribution, tracking and quality control. 5+ years of experience in drug development especially in labelling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. ~ Electronic document management systems use and / or electronic submission experience ~ Regulatory Information Management System (RIMS), electronic document management system (EDMS). Ability to manage the review and approval of labeling in a document management system. ~ Fluent in English written and spoken
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