Regulatory Affairs AssociateBrussels, Belgium
Since April 2015
Responsible Regulatory Affairs within Zambon, tasks listed hereunder:
Ensure registration of new products and maintenance of existing registrations through reviewing regulatory standards, implementing best practices in line with the current legislation, preparing regulatory documents, submission and follow-up of dossiers during the whole procedure.
Act as the link between the company, its products and the regulatory body.
Ensure compliance with current legislation and guidelines (quality check of dossiers, leaflets, etc.)
Updating of the global regulatory database for assigned products
Handeling of QA, Complaints, Pharmacovigilances cases, submission of Psurs...
CommunicativeCoordinationEfficiencyKindnessOptimismProactivityProblem solvingResult OrientedSociabilityTrustInterest in knowledgeAttention to detail
ApplicationsAdverse Events (AE)Drug regulatory authoritiesDrug Safety and PharmacovigilanceeCTDEnglishHealthcareICH guidelinesMicrosoft OfficeMultilingualNew Drug Application (NDA)Pharmaceutical IndustryRegulatory affairsRegistration of the productRegulatory ComplianceRegulatory RequirementsRegulatory submissions
Skills and Expertise
Administrative supportAdverse event reportingApprove patient informationAssemble regulatory applicationsFollow up projectsGenerate regulatory submissions General office managementManage regulatory activitiesPeople managementPrepare regulatory documentsPrepare responses to health authority queriesPromotional materialsRegulatory submissions