Years of experience: 7

CopywritingTranslatorTechnical TranslatorCustomer ServiceConsultingMedical

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Tatiana's Career Path
Regulatory Affairs OfficerMay. 2023 -
Present
PHARMASSIST LTDRegulatory Affairs Officer
Athens, 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 (espec...
CMC Regulatory Affairs & Compliance OfficerDec. 2021 -
Apr. 2023
UNI-PHARMA Pharmaceutical Laboratories S.A.CMC Regulatory Affairs & Compliance Officer
Athens, 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 ...
Pharmacy Store ManagerFeb. 2021 -
Nov. 2021
Pharmacy295Pharmacy Store Manager
Athens, 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

Tatiana's Posts

  • How I can help you

    Handling of Marketing Authorization applications, variation and renewal procedures submitted via MRP, DCP, CP & NPs. *Preparation of Module 1 documents for the above procedures

  • People I am looking for

    Ideal for startups and pharma companies. Focus on compliance and quality assurance to meet regulatory standards.

  • Experience & Cases

    Experienced working in multinational teams, collaborating with with agencies, CROs, and Marketing Authorization Holders for diverse regulatory needs.

  • How to contact

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