About the role
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.
The starting salary for this position will be shared with shortlisted candidates prior to the interview.
Text as published by Demo S.A.. We don't edit postings; apply and ask questions on the employer's site.