At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs - Europe (Pre-Approval) Supervisor to join our team. This position is based in Athens, Kryoneri.
Responsibilities:
- Lead EU pre‑approval regulatory strategy and documentation requirements.
- Own end‑to‑end dossiers for DCP/MRP/National submissions, ensuring quality and on‑time delivery.
- Line-manage/coach Regulatory Affairs Officers & Associates; review and sign off key deliverables.
- Act as primary liaison with EU Regulatory Authorities; coordinate responses to questions/deficiencies.
- Drive cross‑functional input for dossier compilation and maintain compliance for the registered portfolio.
- Understanding of Regulatory strategy and documentation requirements.
- Act as responsible Regulatory Team member for assigned regulatory projects.
- 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.
- Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities.
Requirements
- BSc Degree in Pharmacy, Biology or relevant field.
- 5+ years of experience in Regulatory within a Pharmaceutical organization ideally in similar position.
- 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 EU 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.