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