# Regulatory Affairs Coordinator

**Company:** [VIANEX](http://jobs.workable.com/companies/52NxvE7Q5vHtRBviuPYy8h.md)
**Location:** Gerakas, Greece
**Workplace:** on site
**Department:** Regulatory Affairs

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## Description

-   Preparation of product dossiers and submission to National Organization for Medicines (EOF), European Medicines Agency (EMA), or other relevant competent authorities for approval, variation, and renewal procedures.
-   Preparation of eCTD dossiers and submissions via CESP.
-   Correspondence with partner companies/agents to obtain and provide information related to dossier submissions to EOF or other competent authorities.
-   Preparation and revision of SPCs (Summary of Product Characteristics) and PILs in collaboration with the relevant Medical Affairs departments.

## Requirements

-   2-3 years of relevant experience in a pharmaceutical company.
-   Degree in Pharmacy, Chemistry, Biology, Biochemistry, or other related Life Sciences field.
-   Excellent command of the English language.
-   Good computer literacy.

## Benefits

-   Excellent working environment
-   Competitive remuneration package
-   Opportunities for professional growth and development