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Regulatory labelling specialist

Ozieri
Advanced Resource Managers
Pubblicato il Pubblicato 17h fa
Descrizione

PAdvanced Resource Managers are currently searching for a Regulatory Labelling Specialist for one of our clients, a small but growing consultancy. /ppYou will be involved with the following responsibilities within the role : /pulliManage the labeling review and approval processes. /liliSupport the creation and maintenance of regulatory compliant documents. /liliWork closely with the Medical Affairs team to provide medical relevance assessment and labeling guidance. /liliConduct text comparisons (originator, reference vs. generic). /liliDocument and monitor all global and local changes for the assigned portfolio of brands / products. /liliContribute to labeling process improvement initiatives. /li /ulpbSkills / Experience needed /b /pliDegree qualified /lili3+ years of labeling experience within the pharma industry (generics) or experience in regulatory affairs. /liliUnderstanding of labeling changes. /liliSolid knowledge of labeling guidelines and regulations. /liliExperience in documentation and archiving. /liliExperience with DocuBridge and DrugTrack is an advantage. /liliTeam player with good communication skills. /lipIf you are interested in this opportunity, please contact Vik Patel at ARM. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr

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