Regulatory Affairs Post-approval Senior Officer

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.