Regulatory Affairs CMC Officer

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

Benefits:
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.