Regulatory Affairs Pre-approval Officer
1 week ago
At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Pre-approval Officer 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.
- Preparation of module I documentation for DCP, MRP and National applications in line with 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.
- 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
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
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