Regulatory Affairs (Pre-Approval) Supervisor

Regulatory Affairs (Pre-Approval) Supervisor

DEMO Pharmaceuticals

Athens, Greece

Description

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs (Pre-Approval) Supervisor to join our team. This position is based in Athens, Kryoneri.

Responsibilities:

• Understanding of Regulatory strategy and documentation requirements;
• Act as responsible Regulatory Team member for assigned regulatory projects;
• Overall regulatory documentation for DCP, MRP and National applications in line with assigned timelines;
• Coach, guide and review deliverables of Regulatory Affairs Officers and Associates;
• Liaise with external Regulatory authorities as required;
• 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;
• Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities.

Requirements

• BSc Degree in Pharmacy, Biology or relevant field;
• 5+ years of experience in Regulatory within a Pharmaceutical organization;
• Fluent in English and good MS Office skills;
• Strong organization skills, multi-tasking and able to meet deadlines;
• Effective communication and relationship management;
• Knowledge of EU regulatory guidelines;
• Ability to work under pressure, resilience.

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