Regulatory Affairs - Europe (Pre-Approval) Supervisor
Demo S.A.· Regulatory Affairs
About this 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.
- 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
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs - Europe (Pre-Approval) Supervisor position at Demo S.A.?
The salary for this Regulatory Affairs - Europe (Pre-Approval) Supervisor role at Demo S.A. is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs - Europe (Pre-Approval) Supervisor position at Demo S.A. located?
This Regulatory Affairs - Europe (Pre-Approval) Supervisor role at Demo S.A. is based in Athens, Attica, Greece. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs - Europe (Pre-Approval) Supervisor role at Demo S.A. full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Affairs - Europe (Pre-Approval) Supervisor role in the Regulatory Affairs department at Demo S.A..
Which team or department does the Regulatory Affairs - Europe (Pre-Approval) Supervisor at Demo S.A. belong to?
This Regulatory Affairs - Europe (Pre-Approval) Supervisor position is part of the Regulatory Affairs department at Demo S.A.. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regulatory Affairs - Europe (Pre-Approval) Supervisor position at Demo S.A.?
Click the "Apply Now" button on this page. You will be redirected to Demo S.A.'s official application portal hosted on workable where you can submit your application directly.
When was the Regulatory Affairs - Europe (Pre-Approval) Supervisor job at Demo S.A. posted?
This Regulatory Affairs - Europe (Pre-Approval) Supervisor position at Demo S.A. was posted on Jun 19, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs - Europe (Pre-Approval) Supervisor
Demo S.A.
You'll be redirected to Demo S.A.'s official application page on workable.