regulatory affairs post-approval senior officer
Oct 7, 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…
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.