Regulatory Affairs Post-approval Senior Officer

Regulatory Affairs Post-approval Senior Officer

DEMO Pharmaceuticals

Athens, Greece

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.