Regulatory Affairs CMC Senior Officer

Regulatory Affairs CMC Senior 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 Senior 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.