regulatory affairs officer.

For the Regulatory Affairs Officer position the company offers competitive salary.

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

• Adhering to Local/Global SOPs & Policies to ensure Regulatory compliance
• Performing activities related to Regulatory lifecycle management of Marketing Authorizations (e.g. variations, renewals, new registrations). Follow-up approval of submissions
• Setting up and communicating responses to Health Authorities
• Producing and ensuring compliance and consistency of product information, labeling and packaging
• Maintaining internal Regulatory databases and Document Management Systems. Executing administrative processes of the department
• Updating Regulatory SOPs. Ensuring compliance with Regulatory and Quality audit requirements
• Handling Product Complaints as per company procedures
• Supporting Regulatory and Quality aspects of PV activities: Submitting RMPs, ARMMs, DHPC letters to Health Authorities and ensuring implementations. Supporting PV in Quality audits

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? You can call me at +306940601921 and ask for Thenia Vougiouka. Otherwise, feel free to contact me at tvougiouka@randstad.gr. 

Παρακαλούμε λάβετε υπόψη ότι για λόγους διαφάνειας και ισότιμης μεταχείρισης, θα αξιολογήσουμε μόνο τις αιτήσεις που υποβάλλονται μέσω του site μας. Μετά τη συλλογή και αξιολόγηση όλων των βιογραφικών σημειωμάτων θα επικοινωνούμε μόνο με τους/τις υποψηφίους/ες που ανταποκρίνονται στις απαιτήσεις της θέσης προς στελέχωση προκειμένου να οριστεί συνάντηση για συνέντευξη. Όλες οι αιτήσεις θεωρούνται απόλυτα εμπιστευτικές. 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.