About the role
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.
The starting salary for this position will be shared with shortlisted candidates prior to the interview.
Text as published by Demo S.A.. We don't edit postings; apply and ask questions on the employer's site.