Regulatory Affairs Senior CMC Officer
Η θέση δε δέχεται πλέον αιτήσεις
501-2000
Φαρμακευτικές & Κλάδος Υγείας
πριν 2 μήνες
Ημ. ανάρτησηςπριν 2 μήνες
Entry / ΑρχάριοςΕπίπεδο εμπειρίας
Entry / ΑρχάριοςΠλήρης απασχόλησηΤύπος απασχόλησης
Πλήρης απασχόλησηΕπιστημονικός ΚλάδοςΚατηγορία θέσης
Επιστημονικός ΚλάδοςDEMO 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
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ
Regulatory Affairs Senior CMC Officer
Αθήνα
πριν 2 μήνες
Entry / Αρχάριος
Πλήρης απασχόληση