Regulatory Information Management
Il y a 3 jours
Belgique
MSI Pharma
Temps plein
75 000 € - 100 000 €/an
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Location: Brussels,Belgium
EngagementStatus: Freelancepositionuntilendof2026withpossibilityofextension
Overview
Wearepartneringwithalargeglobalpharmaceuticalcompanytosupportregulatoryoperationsacrossadiverseproductportfolio.TheRIMOperationsManagersupportsglobalregulatoryteamsbyensuringhigh‑qualityregulatorydata,effectivesystemusage,andstrongprocessgovernanceacrossregulatoryinformationmanagementplatforms.
Key Responsibilities
- Providefirst‑linesupportandtrainingforglobalRIManddocumentmanagementsystems
- Performdataqualitychecksandremediationwithinregulatorydatabases
- Author,review,andmaintainSOPs,validationdocuments,anduserguides
- SupportHealthAuthoritysubmissions,inspections,audits,andCAPAactivities
- Actasaliaisonbetweenregulatoryusers,dataowners,andgovernancegroups
Requirements
- ExperienceworkingwithRegulatoryInformationManagement(RIM)systems
- Strongunderstandingofregulatorydata,submissions,andlicensetracking
- Knowledgeofaudits,inspections,andregulateddocumentation
- FamiliaritywithIDMP,controlledvocabularies,andmasterdataconcepts
Hard Skills
- ExperiencewithRegulatoryInformationManagement(RIM)systems
- Regulatorydataqualityandgovernanceexpertise
- Knowledgeofsubmissions,licensetracking,andaudits
- UnderstandingofIDMPandcontrolledvocabularies
Soft Skills
- Strongattentiontodetail
- Analyticalandproblem‑solvingmindset
- Abilitytoworkautonomouslyinregulatedenvironments
- Effectivecommunicationwithglobalstakeholders
Education
- Bachelor’sdegreerequired
- Degreeinlifesciencesorarelateddisciplinepreferred