Regulatory Affairs Officer

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented
Regulatory Affairs Officer
to join our team. This position is based in
Athens, Kryoneri.
Main duties and responsibilities:

• Understanding of Regulatory strategy and documentation requirements


• Act as responsible Regulatory Team member for assigned regulatory projects


• Preparation of documentation for National phase of EU DCP/MRP/National procedures within assigned timelines.


• Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities


• 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


• Preparation of submissions

Requirements
Experience, skills and qualifications required
:

• BSc Degree in Pharmacy, Biology or relevant field


• 1-2 years of experience in Regulatory Affairs


• Fluent in English and good 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.