regulatory affairs officer.

For the Regulatory Affairs Officer position the company offers the following benefits: 

• Opportunity for further career evolution.
• Modern working environment.
• Competitive remuneration package.

The key duties and responsibilities for this Regulatory Affairs Officer position will be the following: 

• Prepares, submits, and monitors pharmaceutical product dossiers (CTD / eCTD).
• Coordinates applications for Marketing Authorisations (MAA), Renewals, and Variations.
• Maintains updated Product Information Files (PIF), SmPC, PIL, and labelling according to the approved format.
• Ensures that labels and leaflets comply with regulatory requirements and legislation.
• Collaborates with the Quality (QA/QC), Production, Marketing, and Export departments on technical and regulatory product matters.
• Monitors changes in legislation (EOF, EMA, EC, ICH, WHO) and informs management accordingly.
• Coordinates communication with authorities for clarifications, supplementary information, and responses to queries.
• Supports the R&D team during new product development by defining regulatory strategies.
• Maintains the archive of regulatory documents, approvals, and correspondence with authorities (Regulatory Archive).
• Participates in internal and external audits/inspections regarding regulatory compliance.
• Ensures product compliance with serialisation, track & trace, and pharmacovigilance requirements.

The qualifications for the Regulatory Affairs Officer position include:

• Life Science Bachelor Degree (pharmacist, biologist, chemist).
• Excellent Knowledge of the English language.
• Good knowledge of Local, EU and International regulatory affairs legislation and guidance.
• Good written communication skills with attention to detail.
• Strong critical thinking and ability of data interpretation.

• 2-3 years Regulatory Affairs Officer experience in a pharmaceutical company 

Does this role sounds like you or someone you know?

We want to hear from you today. Apply online now!

Have some questions first? Call our office at +30 2166001308 and ask for Calypso Aronis. Otherwise, feel free to contact me at caronis@randstad.gr. 

Please note that for transparency and equity reasons, only those applications made online via our site will be assessed. After the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. ​ All applications are considered strictly confidential.