Junior Serialization & Laboratory Software Platforms Administrator
Demo S.A.
Full time
Head of Regulatory Affairs - Europe (Pre-Approval)
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 Head of Regulatory Affairs - Europe (Pre-Approval) 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 Head of Regulatory Affairs - Europe (Pre-Approval) position at Demo S.A.?
The salary for this Head of Regulatory Affairs - Europe (Pre-Approval) 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 Head of Regulatory Affairs - Europe (Pre-Approval) position at Demo S.A. located?
This Head of Regulatory Affairs - Europe (Pre-Approval) 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 Head of Regulatory Affairs - Europe (Pre-Approval) role at Demo S.A. full-time or part-time?
This is listed as a Full time position. It is posted as a Head of Regulatory Affairs - Europe (Pre-Approval) role in the Regulatory Affairs department at Demo S.A..
Which team or department does the Head of Regulatory Affairs - Europe (Pre-Approval) at Demo S.A. belong to?
This Head of Regulatory Affairs - Europe (Pre-Approval) 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 Head of Regulatory Affairs - Europe (Pre-Approval) 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 Head of Regulatory Affairs - Europe (Pre-Approval) job at Demo S.A. posted?
This Head of Regulatory Affairs - Europe (Pre-Approval) position at Demo S.A. was posted on May 27, 2026. Apply as soon as possible — early applications are often reviewed first.
Head of Regulatory Affairs - Europe (Pre-Approval)
Demo S.A.
You'll be redirected to Demo S.A.'s official application page on workable.