Regulatory Affairs Post-approval Senior Officer

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Post-approval Senior Officer (Non-EU markets) to join our team. This position is based in Athens, Kryoneri.

Responsibilities

Understanding of Regulatory strategy and documentation requirements in Non-EU markets ( Middle East, Africa, Asia, CIS, LATAM). Act as responsible Regulatory Team member for assigned regulatory projects. Assist and support the junior personnel of the team for the projects they have undertaken. Collect, prepare, compile regulatory documentation, for the product’s lifecycle maintenance (administrative, quality, safety variations and renewal procedures).

Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities. Liaise with international regulatory authorities, local agents, and distributors. Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary.

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 Preparation of submissions including CMC variation filling.

Requirements

BSc Degree in Chemistry, Biology or relevant field. 2-4 years demonstrated experience managing regulatory submissions in Non- EU markets ( Middle East, Africa, Asia, CIS, LATAM) Fluent in English and good MS Office skills Good command of eCTD software and CESP platform. Strong organization skills, multi-tasking and able to meet deadlines Effective communication and relationship management Knowledge of EU and global regulatory guidelines Ability to work under pressure, resilience Benefits The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.