Experience

Medochemie Ltd

• Cyprus
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Regulatory Affairs Specialist

  • May 2022 - Present



ANFARM

• Greece
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Jun 2021 - Mar 2022

  • Responsible for registration activities mainly in Europe and submitting applications for marketing authorizations (DCPs, MRPs and national applications), coordinating and reviewing responses to DLs, life cycle management of MAs (renewals, variations, sunset clause exemption requests, withdrawals) - communication with regulatory authorities and clients (very good knowledge of EU regulatory guidlines)• Preparation of product information texts according to QRD template and guidelines.• eCTD preparation and sequences delivery to authorities through CESP• Reviewing of business contracts and agreements and responsible for procurement of RA services. Show less

• • Oct 2020 - Jun 2021

  • Responsible for registration activities in Europe and submitting applications for marketing authorizations (DCPs, MRPs and national applications), coordinating and reviewing responses to DLs, life cycle management of MAs (renewals, variations, sunset clause exemption requests, withdrawals) - communication with regulatory authorities and clients (very good knowledge of EU regulatory guidlines)• Preparation of product information texts according to QRD template and guidelines.• eCTD preparation and sequences delivery to authorities through CESP• Reviewing of business contracts and agreements and responsible for procurement of RA services. Show less



Pharmathen

• Netherlands
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Officer

  • Apr 2018 - Oct 2020

  • Responsible for registration activities in Europe and South Africa: submitting applications for marketing authorizations (CPs, DCPs, MRPs and national applications), coordinating and reviewing responses to DLs, life cycle management of MAs (renewals, variations, sunset clause exemption requests, withdrawals) - communication with regulatory authorities and clients • Project management (coordination of company's departments for registration and launch of products in Europe, South Africa and USA) • Consulted with regulatory representatives to manage filings, applications and reports • CMC experience Show less



Self employed

• Athens, Greece

• Biology Tutor

  • Sep 2010 - Jun 2018

  Preparation of students for National examinations Preparation of students for National examinations



Alexandra General Hospital

• Athens,Greece

• Clinical Study Coordinator

  • Sep 2017 - Mar 2018

  Experience in oncological clinical trials in: • Managed quality assurance program, including on-site evaluations, internal audits and customer surveys based in study protocol and GCP • Patient data management • Drug management (storage, ordering, allocation to patients) • Coordination with sponsors, doctors and patients for therapeutic sessions scheduling according to clinical study protocols Experience in oncological clinical trials in: • Managed quality assurance program, including on-site evaluations, internal audits and customer surveys based in study protocol and GCP • Patient data management • Drug management (storage, ordering, allocation to patients) • Coordination with sponsors, doctors and patients for therapeutic sessions scheduling according to clinical study protocols



Helen's Real Estate

• Athens, Attiki, Greece

• Real Estate Broker Associate

  • Jul 2015 - Dec 2015

  • Developed and deployed marketing collateral to promote properties and drive sales • Monitored territory and capitalized on potential sales opportunities by contacting owners and setting up meetings • Managed list of available properties suited to different needs and budgets for both commercial and industrial use • Developed and deployed marketing collateral to promote properties and drive sales • Monitored territory and capitalized on potential sales opportunities by contacting owners and setting up meetings • Managed list of available properties suited to different needs and budgets for both commercial and industrial use



Greek Army

• Greece

• Microbiology Lab Assistant

  • Sep 2014 - Jun 2015

  Mandatory Army service Mandatory Army service



Helen's Real Estate

• Athens, Attiki, Greece

• Real estate broker Assistant

  • Dec 2013 - Jul 2014

  • Developed and deployed marketing collateral to promote properties and drive sales • Maintained efficient office operations by handling all errands and administrative functions • Coordinated appointments to show marketed properties • Developed and deployed marketing collateral to promote properties and drive sales • Maintained efficient office operations by handling all errands and administrative functions • Coordinated appointments to show marketed properties