# Regulatory Affairs Post-approval Senior 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/9bef37a0-5e1b-440d-9af9-c4151f43e7fe)

## Description

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Post-approval Senior Officer (Non-EU markets) to join our team. This position is based in Athens, Kryoneri.

Responsibilities:

-   Understanding of Regulatory strategy and documentation requirements in Non-EU markets ( Middle East, Africa, Asia, CIS, LATAM).
-   Act as responsible Regulatory Team member for assigned regulatory projects.
-   Assist and support the junior personnel of the team for the projects they have undertaken.
-   Collect, prepare, compile regulatory documentation, for the product’s lifecycle maintenance (administrative, quality, safety variations and renewal procedures).
-   Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities.
-   Liaise with international regulatory authorities, local agents, and distributors.
-   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 including CMC variation filling.

## Requirements

-   BSc Degree in Chemistry, Biology or relevant field.
-   2-4 years demonstrated  experience managing regulatory submissions in Non- EU markets ( Middle East, Africa, Asia, CIS, LATAM)
-   Fluent in English and good MS Office skills
-   Good command of eCTD software and CESP platform.
-   Strong organization skills, multi-tasking and able to meet deadlines
-   Effective communication and relationship management
-   Knowledge of EU and global 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.