Lavipharm

Senior Specialist, Regulatory Affairs – Pre-Authorization Submissions

Lavipharm

full-time

Posted on:

Location Type: Hybrid

Location: Paiania • Greece

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Job Level

Senior

About the role

  • Leads preparation, review and compilation of CTD/eCTD dossiers for new product applications (MAAs and MATAs)
  • Authors and reviews Module 1 documentation with minimal supervision, including regional/administrative content
  • Contributes to regulatory submission strategy and drives proactive project completion
  • Liaises directly with regulatory authorities during evaluation phases; prepares responses to questions and requests for information
  • Coordinates across functions with key internal stakeholders to ensure dossier completeness and guideline compliance

Requirements

  • BSc in Pharmacy, Chemistry, Biology or a related field (post-graduate decree is a plus)
  • 3–5 years of experience in Regulatory Affairs, with a focus on pre-authorization or new product submissions
  • Strong knowledge of EU/ICH regulatory requirements, CTD/eCTD format and submission processes
  • Excellent command of the Greek and English language (written and spoken)
  • Strong computer literacy
  • Proven ability to manage multiple projects, handle competing priorities and work under pressure
Applicant Tracking System Keywords

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

Hard Skills & Tools
CTDeCTDregulatory submission strategyEU regulatory requirementsICH regulatory requirementsproject managementdocumentation authoringdossier compilationsubmission processes
Soft Skills
communicationproject completioncoordinationmultitaskinghandling competing prioritiesworking under pressure
Certifications
BSc in PharmacyBSc in ChemistryBSc in Biologypost-graduate degree