regulatory affairs post-approval senior officer
Aug 2, 2026 · DEMO S.A. Pharmaceutical Industry
What you'll do
- Understand Regulatory strategy and documentation requirements in Non-EU markets
- Act as responsible Regulatory Team member for assigned regulatory projects
- Assist and support junior personnel in their projects
- Collect, prepare, and compile regulatory documentation for product lifecycle maintenance
- Compile and monitor progress of scientific responses to regulatory authority deficiencies
- Liaise with international regulatory authorities, local agents, and distributors
- Ensure policies and procedures are properly understood and carried out
- Liaise with departments to collect necessary information and documentation for dossier submission
- Support internal Regulatory department activities to ensure compliance
- Prepare submissions including CMC variation filings
Key requirements
- 2+ years' experience
- Regulatory strategy and documentation requirements in Non-EU markets
- Managing regulatory submissions
- eCTD software and CESP platform
- MS Office skills and organization skills
- Knowledge of EU and global regulatory guidelines
- Effective communication skills, ability to work under pressure, resilience
- Chemistry / Biology / Relevant field
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 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.
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.