Officer Regulatory Affairs, Lifecycle Management
Paiania, Attica, GreeceRemoteFull-time
AI Summary
An Officer Regulatory Affairs (Lifecycle Management) at Lavipharm in Greece ensures marketed products remain legislatively compliant by managing renewals, variations, CTD/Module 1 dossiers, and multi-market submission timelines.
About this role
Lavipharm is seeking an Officer Regulatory Affairs for Lifecycle Management based in Athens who will be responsible for ensuring marketed products maintain full legislative compliance. The accountabilities include preparing dossiers, managing timelines and supporting multi-market submissions.
Key Responsibilities
- Execute routine regulatory activities: renewals, variations, CTD/Module 1 preparation
- Monitor and manage timelines for MA variations, post-authorization activities and renewal applications
- Prepare and submit import/export applications for medicinal products
- Review and update packaging materials and artworks in line with current guidelines
- Maintain regulatory databases and departmental filing systems
Requirements
- BSc in Pharmacy, Chemistry, Biology or a related field
- 1–2 years of experience in a Regulatory Affairs role within the pharmaceutical industry
- Familiarity with EU regulatory legislation and eCTD submission processes
- Excellent command of the Greek and English language (written and spoken)
- Very good computer literacy
Skills
CTDECTD SubmissionEU Regulatory LegislationImport/export ApplicationsLifecycle ManagementModule 1Regulatory RenewalsVariations Management
