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Work Background
PHARMASSIST LTDRegulatory Affairs Officer
May. 2023Athens, Attiki, GreeceMy experience lies on: *Handling of Marketing Authorization applications, variation and renewal procedures submitted via MRP, DCP, CP & NPs.
*Preparation of Module 1 documents for the above procedures
*Communications with Health Authorities during the procedures mentioned and submitting Responses to Deficiency Letters, ensuring successful End of Procedure.
*Compilation of eCTD dossiers (especially for Modules 1-3)
*Communication with Stakeholders for the preparation and submission of required documentation during Initial Registrations, Variations, Renewals in EU and RoW markets.
*Reviewing and preparation of Mock-ups & Product Information materials
*Reviewing and providing feedback on approval/rejection of Promotional Materials
*Monitoring of Greek and EU legislation & guidelines
*Maintaining and updating internal databases ensuring compliance and readiness for Internal/External Audits
*Experienced using Platforms/Software managing Regulatory Content & Data such as Veeva Vault, Webcenter.
UNI-PHARMA Pharmaceutical Laboratories S.A.CMC Regulatory Affairs & Compliance Officer
Dec. 2021 - Apr. 2023Athens, Attiki, Greece- Contributing to the compiling of Quality Overall Summary and Quality Module of the Common Technical Document for human medicinal products (Modules 2.3 & 3.2)
- Reviewing and answering comments from Regulatory Authorities (RMS, CMS) during the assessment period of national, MRP and DCP applications. - Establishing regulatory compliance for marketing authorisation applications in EU & non EU countries.
- Contact Point for API suppliers, regarding regulatory compliance documents.
Pharmacy295Pharmacy Store Manager
Mar. 2021 - Nov. 2021Athens, Attiki, Greece- In charge of all day to day activities
- Managing the orders & supply chain for medicinal stock, supplements, cosmetics
- Organized weekly staff meetings & training workshops
- Handling and resolving complaints
- Participating in the hiring process for pharmacy staffing
Pharmacy295Senior Pharmacist
Nov. 2019 - Mar. 2021Athens, Attiki, Greece
National Institute for Health and Welfare (THL)Student Intern
Apr. 2018 - Jun. 2018Helsinki Area, FinlandFor the final 3 months of my master studies, I was an intern at the National Institute for Health and Welfare in Helsinki, Finland, where I conducted my master thesis in pharmaceutical regulation/deregulation policies and reforms. The highlight of this experience was the possibility to conduct in-depth interviews with experts and stakeholders in the Helsinki area.
Medochemie LtdQuality Assurance Associate (Pharmacist)
Apr. 2016 - Oct. 2016LimassolMy responsibilities included the reviewing of production and packaging batch records and standard operating procedures. I received GMP training and training on the procedure of internal audits. Had to make sure that personnel behavior and activity complied with GMP regulations.
Peter Pharmacies ltdSenior Pharmacist
Sep. 2014 - Mar. 2016Nicosia, CyprusMy responsibilities included patient-customer service, prescriptions management, stock maintenance and both daily and monthly check of supplies and orders placement. I was a senior pharmacist and had under my watch an assistant pharmacist and a trainee pharmacist.
Sarafianos private clinicHospital Pharmacist
Jun. 2014 - Aug. 2014Thessaloniki, Greece
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