Lavipharm

Lead Regulatory Affairs, Lifecycle Management

Lavipharm

full-time

Posted on:

Location Type: Hybrid

Location: Paiania • Greece

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Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategylifecycle activitiesdossier preparationsubmission managementpharmacovigilance complianceattention to detailEU regulatory legislationinternational regulatory guidance
Soft Skills
negotiationcollaborationmentoringcommunication
Certifications
BSc PharmacyBSc ChemistryBSc Biologypost-graduate degree