Regulatory Affairs Post-approval Senior Officer
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Before you apply
LocationAthens, Attica, Greece
Work modeon-site
Typefull-time
SenioritySenior
Experience2–4 yrs
DepartmentRegulatory Affairs
Company size501–1,000 people
PostedMar 6, 2026 · 8mo ago
Verified live2d ago
May no longer be actively hiring
Posted by the company on Mar 6, 2026
At a glanceSummarised by Seekless from the posting.
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
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
Skills
MS Office
eCTD
CESP
Benefits
Competitive salary
Training
Career development
Friendly environment
About the 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
Responsibilities:
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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.
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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.
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Liaise with international regulatory authorities, local agents, and distributors.
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Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary.
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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.