Regulatory Affairs CMC Officer

Regulatory Affairs CMC Officer

DEMO Pharmaceuticals

Athens, Greece

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;
• Prepare, review, and maintain CMC documentation for regulatory submissions in Europe and rest of the world (ROW) ensuring compliance with current GMP, ICH, and other relevant regulatory guidelines;
• Prepare and coordinate responses to Deficiency Letters (DLs) and other CMC-related regulatory queries in collaboration with cross-functional teams;
• Liaise with with R&D, QA, Regulatory Affairs, and Manufacturing teams to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration;
• Liaise with external Regulatory authorities as required;
• Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products.

Requirements

• BSc Degree in Chemistry, Pharmacy, Biology or relevant field;
• More than 3 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.