Lavipharm is seeking a Lead Regulatory Affairs, Lifecycle Management based in Athens who will be the regulatory engine behind our approved product portfolio. The role will manage complex submissions independently, negotiate directly with regulatory agencies and ensure our marketing authorizations remain current across all markets, from launch through to divestment.
Key Responsibilities
- Lead regulatory strategy and lifecycle activities (renewals, variations, CTD maintenance) across a multi-country product portfolio
- Direct preparation and submission of dossiers, managing complexity with minimal escalation
- Interact and negotiate directly with EU and international regulatory authorities on post-authorization activities, variations, and renewals
- Formulate RA policies and ensure compliance across pharmacovigilance, packaging, and promotional materials
- Collaborate across functions with key internal stakeholders and mentor junior team members
Requirements
- BSc Pharmacy, Chemistry, Biology, or a related field (post-graduate decree is a plus)
- More than 6 years of Regulatory Affairs professional experience in the pharmaceutical industry
- Solid knowledge of EU and international RA legislation and guidance
- Proven track record of managing submissions independently with strong attention to detail
- Excellent command of the Greek and English language (written and spoken)
- Strong computer literacy
