regulatory affairs - europe (pre-approval) supervisor
Aug 2, 2026 · DEMO S.A. Pharmaceutical Industry
What you'll do
- Lead EU pre-approval regulatory strategy and documentation requirements
- Own end-to-end dossiers for DCP/MRP/National submissions ensuring quality and timely delivery
- Line-manage and coach Regulatory Affairs Officers and Associates; review and approve key deliverables
- Act as primary liaison with EU Regulatory Authorities and coordinate responses to questions and deficiencies
- Drive cross-functional input for dossier compilation and maintain compliance for registered portfolio
- Ensure policies and procedures are understood, evaluated, and implemented with necessary modifications
- Liaise with various departments to collect required information and documentation for dossier submission and product registration
- Support internal Regulatory department activities to ensure compliance of registered products
- Compile and monitor scientific responses to deficiencies raised by Regulatory authorities
Key requirements
- 5+ years' experience
- Regulatory strategy with knowledge of EU regulatory guidelines and dossier preparation for DCP/MRP/National submissions
- Line management and coaching with effective communication and relationship management skills
- Liaison with EU Regulatory Authorities and cross-functional coordination
- Policy and procedure understanding with ability to work under pressure and resilience
- MS Office skills with strong organizational and multitasking abilities
- Fluent English
- Pharmacy / Biology
Benefits
- The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
About the job
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.
About the company
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products.
The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe.
Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology.
At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece.
DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone.
About the company
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products.
The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe.
Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology.
At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece.
DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone.