Regulatory Affairs - Europe (Pre-Approval) Supervisor

Stellenbeschreibung:

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