# Senior Specialist Regulatory Affairs, Pre-Authorization Submissions

> Lavipharm · Paiania, Greece (Hybrid) · Full-time · Posted 2026-03-13

**Workplace:** hybrid

**Department:** Regulatory Affairs

## Description

Lavipharm is seeking a **Senior Specialist Regulatory Affairs, Pre-Authorization Submissions** based in Athens, who will play a central role in progressing the pipeline and expanding the current portfolio into new markets. In relation to Pre-Authorization Submissions, the role will lead the preparation and coordination of CTD/eCTD dossiers for new marketing authorization applications, working closely with cross-functional teams to drive submissions through to approval. The role operates with a high degree of independence, engages directly with regulatory authorities and provides strategic input to the submission process.

### Key Responsibilities

-   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

## Apply

[Apply at Lavipharm](https://apply.workable.com/lavipharm/j/8482F9C72F/apply)

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