Officer Regulatory Affairs, Lifecycle Management

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