Regulatory Affairs Officer

Regulatory Affairs Officer

DEMO Pharmaceuticals

Athens, Greece

Description

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.