Regulatory Affairs Post-approval Senior Officer

Stellenbeschreibung:

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