# Regulatory Affairs - Europe (Pre-Approval) Supervisor

**Company:** [Demo S.A.](http://jobs.workable.com/companies/bfFZ3SuxMR5zjdkBWmB1yU.md)
**Location:** Athens, Greece
**Workplace:** on site
**Employment type:** Full-time
**Department:** Regulatory Affairs

[Apply for this job](http://jobs.workable.com/view/dce59a45-b071-4cd4-9014-a5c0b1a51a89)

## Description

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented **Regulatory Affairs - Europe (Pre-Approval) Supervisor** to join our team. This position is based in **Athens, Kryoneri.**

**Responsibilities:**

-   Lead EU pre‑approval regulatory strategy and documentation requirements.[](https://outlook.office365.com/owa/?ItemID=AAMkAGZmNWQ3MTJhLWY1Y2UtNGM1YS1iMTk1LThmY2ZiNmI1MjNjMgBGAAAAAAAGAdcPnqZ8TZP0N%2fn2EQ2TBwDWPb%2fTT%2fNdQZGuTNoUvtFVAAAF4wKKAADWPb%2fTT%2fNdQZGuTNoUvtFVAAAF46p2AAA%3d&exvsurl=1&viewmodel=ReadMessageItem)
-   Own end‑to‑end dossiers for DCP/MRP/National submissions, ensuring quality and on‑time delivery.
-   Line-manage/coach Regulatory Affairs Officers & Associates; review and sign off key deliverables.[](https://outlook.office365.com/owa/?ItemID=AAMkAGZmNWQ3MTJhLWY1Y2UtNGM1YS1iMTk1LThmY2ZiNmI1MjNjMgBGAAAAAAAGAdcPnqZ8TZP0N%2fn2EQ2TBwDWPb%2fTT%2fNdQZGuTNoUvtFVAAAF4wKKAADWPb%2fTT%2fNdQZGuTNoUvtFVAAAF46p2AAA%3d&exvsurl=1&viewmodel=ReadMessageItem)
-   Act as primary liaison with EU Regulatory Authorities; coordinate responses to questions/deficiencies.[](https://outlook.office365.com/owa/?ItemID=AAMkAGZmNWQ3MTJhLWY1Y2UtNGM1YS1iMTk1LThmY2ZiNmI1MjNjMgBGAAAAAAAGAdcPnqZ8TZP0N%2fn2EQ2TBwDWPb%2fTT%2fNdQZGuTNoUvtFVAAAF4wKKAADWPb%2fTT%2fNdQZGuTNoUvtFVAAAF46p2AAA%3d&exvsurl=1&viewmodel=ReadMessageItem)
-   Drive cross‑functional input for dossier compilation and maintain compliance for the registered portfolio.
-   Understanding of Regulatory strategy and documentation requirements.
-   Act as responsible Regulatory Team member for assigned regulatory projects.
-   Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary.
-   Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration.
-   Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products.
-   Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities.

## Requirements

-   BSc Degree in Pharmacy, Biology or relevant field.
-   **5+ years of experience in Regulatory within a Pharmaceutical** organization ideally in similar position.
-   Fluent in English and good MS Office skills
-   Strong organization skills, multi-tasking and able to meet deadlines
-   Effective communication and relationship management
-   Knowledge of EU regulatory guidelines
-   Ability to work under pressure, resilience

## Benefits

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.