Regulatory Affairs Officer 573

We are urgently seeking for a Regulatory Affairs Officer responsible for ensuring the delivery of regulatory activities performed on the global level.
ResponsibilitiesTo contribute to the production of client administrative documents to be included in regulatory submissionsCompile regulatory dossiers in accordance with national requirementsSystems Management and AdministrationDocument and track regulatory submissions and regulatory authority approvalProvide regulatory support to clients and associate companiesLiaise with external regulatory authorities as requiredProvide review of packaging textsProvide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (e.g. QRD compliance check)Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectivesContribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hubAssist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)Assist in the management of ProductLife Ltd's Quality Management SystemProfileBachelor's degree in a science related field, or A levels with data entry experienceExperience of 1-3 years of RA experience for the pharma industryGood mastering of English and Spanish languagesExcellent organizational and interpersonal skillsAbility to work well within an international and remote teamProcess orientated with good attention to detailEffective oral and written communication skillsGood computer skills and the ability to learn appropriate softwareGood understanding of regulatory tracking database software, eDMS, MS Word, MS Excel#J-18808-Ljbffr