Regulatory Affairs Senior CMC Officer

Regulatory Affairs Senior CMC Officer

DEMO Pharmaceuticals

Athens, Greece

Description

DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is currently looking for a talented Regulatory Affairs CMC Officer to join our team in Athens (Kryoneri). This position reports directly to the Regulatory Affairs CMC Manager.

Main duties and responsibilities:

• Understanding of Regulatory strategy and documentation requirements;
• Act as responsible Regulatory Team member for assigned regulatory projects;
• 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;
• Liaise with external Regulatory authorities as required;
• Preparation of submissions including CMC variation filling.

Requirements

• BSc Degree in Chemistry, Biology or relevant field;
• 4-6 years of experience in Regulatory Affairs/CMC within a Pharmaceutical organization;
• Knowledge of CMC and global regulatory guidelines;
• Fluency in English and good use of MS Office skills;
• Strong organization skills, multi-tasking and able to meet deadlines;
• Effective communication and relationship management;
• Ability to work under pressure, resilience.

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