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