Regulatory Affairs Senior Officer

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

Responsibilities:

• Implement the Regulatory strategy and understand relevant documentation requirements
• Act as responsible Regulatory Team member for assigned regulatory projects
• Review 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 that 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, Chemistry, Biology or relevant field.
• 3+ years of experience in Regulatory Affairs / CMC 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 CMC 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.