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Regulatory labelling specialist

Ozieri
Advanced Resource Managers
50.000 € - 70.000 € all'anno
Pubblicato il 22 agosto
Descrizione

Advanced Resource Managers are currently searching for a Regulatory Labelling Specialist for one of our clients, a small but growing consultancy. You will be involved with the following responsibilities within the role : Manage the labeling review and approval processes. Support the creation and maintenance of regulatory compliant documents. Work closely with the Medical Affairs team to provide medical relevance assessment and labeling guidance. Conduct text comparisons (originator, reference vs. generic). Document and monitor all global and local changes for the assigned portfolio of brands / products. Contribute to labeling process improvement initiatives. Skills / Experience needed Degree qualified 3 years of labeling experience within the pharma industry (generics) or experience in regulatory affairs. Understanding of labeling changes. Solid knowledge of labeling guidelines and regulations. Experience in documentation and archiving. Experience with DocuBridge and DrugTrack is an advantage. Team player with good communication skills. If you are interested in this opportunity, please contact Vik Patel at ARM. J-18808-Ljbffr J-18808-Ljbffr

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