Job Description
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.
