# Regulatory Affairs Officer

**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/013b2c56-7219-44ad-b38c-7a317c8039c2)

## Description

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

**Main duties and responsibilities:**

-   Understanding of Regulatory strategy and documentation requirements.
-   Act as responsible Regulatory Team member for assigned regulatory projects.
-   Preparation of documentation for National phase of EU DCP/MRP/National procedures within assigned timelines. 
-   Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities.
-   Liaise with external Regulatory authorities as required.
-   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.
-   Preparation of submissions.

## Requirements

**Experience, skills and qualifications required**:

-   BSc Degree in Pharmacy, Biology or relevant field.
-   1-2 years of experience in Regulatory Affairs .
-   Fluent in English and good MS Office skills.
-   Strong organization skills, multi-tasking and able to meet deadlines.
-   Effective communication and relationship management.
-   Ability to work under pressure, resilience.

## Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.