regulatory affairs post-approval senior officer
2 Αυγ 2026 · DEMO S.A. Pharmaceutical Industry
Τι θα κάνεις
- Κατανοείς τη ρυθμιστική στρατηγική και απαιτήσεις τεκμηρίωσης σε αγορές εκτός ΕΕ
- Λειτουργείς ως υπεύθυνο μέλος της ρυθμιστικής ομάδας για ανατεθειμένα έργα
- Βοηθάς και υποστηρίζεις το νεότερο προσωπικό της ομάδας στα έργα τους
- Συλλέγεις, προετοιμάζεις και οργανώνεις ρυθμιστική τεκμηρίωση για τη συντήρηση κύκλου ζωής προϊόντων
- Συντάσσεις και παρακολουθείς επιστημονικές απαντήσεις σε παρατηρήσεις ρυθμιστικών αρχών
- Επικοινωνείς με διεθνείς ρυθμιστικές αρχές, τοπικούς πράκτορες και διανομείς
- Βεβαιώνεις την τήρηση πολιτικών και διαδικασιών και αναλύεις τυχόν τροποποιήσεις
- Συντονίζεις τη συλλογή απαιτούμενων πληροφοριών για υποβολές φαρμακευτικών φακέλων
- Υποστηρίζεις τις εσωτερικές δραστηριότητες για τη διασφάλιση ρυθμιστικής συμμόρφωσης
- Προετοιμάζεις υποβολές, συμπεριλαμβανομένων και αλλαγών σε CMC
Βασικές προϋποθέσεις
- 2+ χρόνια εμπειρίας
- Ρυθμιστική στρατηγική και απαιτήσεις ρυθμιστικής τεκμηρίωσης σε αγορές εκτός ΕΕ
- Διαχείριση ρυθμιστικών υποβολών και γνώση λογισμικού eCTD και πλατφόρμας CESP
- Γνώση οδηγιών ρυθμιστικών αρχών της ΕΕ και παγκοσμίως
- MS Office και ικανότητες οργάνωσης και πολλαπλών εργασιών
- Επικοινωνιακές δεξιότητες και σχέση με ρυθμιστικές αρχές
- Ικανότητα εργασίας υπό πίεση και ανθεκτικότητα
- Chemistry / Biology / Relevant field
Παροχές
- Η εταιρεία προσφέρει ανταγωνιστικό μισθό και παροχές, συνεχή εξειδικευμένη εκπαίδευση, επαγγελματική ανάπτυξη και φιλικό εργασιακό περιβάλλον.
Περιγραφή Θέσης
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Post-approval Senior Officer (Non-EU markets) to join our team. This position is based in Athens, Kryoneri.
Responsibilities:
Understanding of Regulatory strategy and documentation requirements in Non-EU markets ( Middle East, Africa, Asia, CIS, LATAM).
Act as responsible Regulatory Team member for assigned regulatory projects.
Assist and support the junior personnel of the team for the projects they have undertaken.
Collect, prepare, compile regulatory documentation, for the product’s lifecycle maintenance (administrative, quality, safety variations and renewal procedures).
Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities.
Liaise with international regulatory authorities, local agents, and distributors.
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
Preparation of submissions including CMC variation filling.
Requirements
BSc Degree in Chemistry, Biology or relevant field.
2-4 years demonstrated experience managing regulatory submissions in Non- EU markets ( Middle East, Africa, Asia, CIS, LATAM)
Fluent in English and good MS Office skills
Good command of eCTD software and CESP platform.
Strong organization skills, multi-tasking and able to meet deadlines
Effective communication and relationship management
Knowledge of EU and global 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.
Περιγραφή Εταιρείας
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.
Περιγραφή Εταιρείας
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.