Summary
Overview
Work History
Education
Skills
Websites
Certification
Awards
Publications
Software
Timeline
Generic
Eleni Kardala

Eleni Kardala

Pharmacist, Regulatory Affairs Professional
Athens

Summary

Proficient in current pharmaceutical products and medical devices regulations, standards, and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.

Overview

8
8
years of professional experience
8
8
years of post-secondary education
4
4
Certifications
4
4
Languages

Work History

Regulatory Affairs Associate

Win Medica Pharmaceutical SA
5 2021 - Current
  • Support of regulatory compliance related activities of pharmaceutical products
  • Handling of marketing authorisation applications
  • Maintenance of drug licences through variations and renewal procedures for EMEA via DCP/MRP, CP and national procedure
  • Communication with agencies, with clients and internally Providing solutions to commercial from a RA perspective Review of labeling and promotional material for pharmaceutical products and medical devices Registering and regulatory monitoring medical devices

Pharmacy Specialist

Private pharmacy
11.2019 - 04.2021
  • Management of pharmaceutical supplies Preparation of galenic products Counselling patients on proper drug use

Lecturer

IEK DELTA
10.2020 - 02.2021
  • Teaching: Pharmacology-Toxicology
  • Pharmaceutical Technology, Statistics, Chemistry

Research Intern in Pharmacology and Pharmacotehnology Lab

Biomedical Research Foundation of the Academy of Athens
05.2017 - 07.2017
  • Technical assistance in research projects performing HPLC analysis and cell cytotoxicity assays

Pre-registration Pharmacist

Sotiria General Hospital of Athens
02.2017 - 04.2017
  • Drug classification, Μanagement of pharmaceutical and sterile medical supplies, Preparation of galenic products, Execution of electronic prescriptions

Quality Assurance

Pharmathen
07.2016 - 09.2016
  • Writing of SOPs (Standard Operation Procedures), Product Quality Review Reports, Process Validation Protocols, CAPA

Education

International MSc in Molecular Biomedicine -

Ethnikon kai Kapodistriakon Panepistimion Athinon and BSRC Fleming
Vari, Greece
01.2017 - 04.2019

Degree, Pharmacy - undefined

Ethnikon kai Kapodistriakon Panepistimion Athinon
01.2012 - 04.2017

Skills

Common Technical Document (CTD)

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Certification

CRED An Overview of Regulatory Product Information

Awards

  • Fellowship by Bodossaki Foundation
  • Scholarship for attending 2nd year of MSc studies in Molecular Biomedicine
  • 2nd prize in AUGMENTED / MIXED REALITY IN HEALTHCARE hackathon

Publications

A Deep Learning Framework for Predicting Response to Therapy in Cancer

Software

Microsoft Office

Timeline

Lecturer

IEK DELTA
10.2020 - 02.2021

Pharmacy Specialist

Private pharmacy
11.2019 - 04.2021

Research Intern in Pharmacology and Pharmacotehnology Lab

Biomedical Research Foundation of the Academy of Athens
05.2017 - 07.2017

Pre-registration Pharmacist

Sotiria General Hospital of Athens
02.2017 - 04.2017

International MSc in Molecular Biomedicine -

Ethnikon kai Kapodistriakon Panepistimion Athinon and BSRC Fleming
01.2017 - 04.2019

Quality Assurance

Pharmathen
07.2016 - 09.2016

Degree, Pharmacy - undefined

Ethnikon kai Kapodistriakon Panepistimion Athinon
01.2012 - 04.2017

Regulatory Affairs Associate

Win Medica Pharmaceutical SA
5 2021 - Current

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Eleni KardalaPharmacist, Regulatory Affairs Professional