Microsoft Office
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)
Microsoft Office
Regulatory Agency Applications
Medical Device Regulations
Analytical Skills
Organizational Skills
Pharmaceutical Regulations
License Maintenance
Compliance Monitoring
Regulatory Strategy
Decision-Making
Multitasking
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
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