Junior Serialization & Laboratory Software Platforms Administrator
Demo S.A.
Full time
Regulatory Affairs Post-approval Senior Officer
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 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.
- 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
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 Regulatory Affairs Post-approval Senior Officer position at Demo S.A.?
The salary for this Regulatory Affairs Post-approval Senior Officer 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 Regulatory Affairs Post-approval Senior Officer position at Demo S.A. located?
This Regulatory Affairs Post-approval Senior Officer 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 Regulatory Affairs Post-approval Senior Officer role at Demo S.A. full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Affairs Post-approval Senior Officer role in the Regulatory Affairs department at Demo S.A..
Which team or department does the Regulatory Affairs Post-approval Senior Officer at Demo S.A. belong to?
This Regulatory Affairs Post-approval Senior Officer 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 Regulatory Affairs Post-approval Senior Officer 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 Regulatory Affairs Post-approval Senior Officer job at Demo S.A. posted?
This Regulatory Affairs Post-approval Senior Officer position at Demo S.A. was posted on Mar 6, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Post-approval Senior Officer
Demo S.A.
You'll be redirected to Demo S.A.'s official application page on workable.