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Work Background
AstraZenecaRegulatory Affairs Manager
Jan. 2024Warsaw, Mazowieckie, Poland- Planning, preparing, handling, distributing and submitting regulatory documents to Health Authorities and/or Marketing Companies, globally, in support of clinical trials. - Providing regulatory expertise on clinical trial related submissions to cross functional teams - Monitoring, interpreting and validating current and changing regulatory legislation in relation to clinical trials and sharing potential impact these activities may have on the product development program. - Performing regulatory review of clinical trial related documents - Document management including updating and tracking study specific regulatory files and systems according to established AZ procedures and regulatory requirements - Ensuring that all work is performed in accordance with established procedures and regulatory requirements - Contribute to improvement of internal processes
ParexelRegulatory Affairs Associate
Jul. 2022 - Jan. 2024Warsaw, Mazowieckie, Poland
ParexelClinical Operations Assistance
Feb. 2022 - Jul. 2022Kyiv City, Ukraine- Maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality.
- Tracking, scanning, filing, entry and return of Case Report Forms to clients for assigned projects, upload and naming of documents in accordance with naming convention to the electronic document management system, EDC User Management activities.
- Maintain basic quality check procedures to ensure accurate maintenance of documents.
- Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers.
- Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance.
- Payment/invoice processing including internal follow up with payment specialists in Finance.
- Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP).
PRJSC INDARProject Manager
Aug. 2020 - Feb. 2022Kyiv, Kyiv City, UkraineManagement of internal, external and international projects.
Communication within projects with partners and the contractors in both native and foreign languages, as a translator and manager.
Analysis of recombinant human insulin manufacture processes in the workshop. The development of new systems and projects for the optimization of the enterprise.
Development of technological schemes and PFDs of the insulin substance production.
Participation in a project of insulin production technology optimization in the laboratory of pharmaceutical development. Conducting analytical methods of target protein qualitative and quantitative determination. Working in the laboratory of pharmaceutical development as an analyst, the development of analytical methods for quality control, validation, statistical processing of results, optimization of documentation for laboratory quality system.
Translation of scientific materials, regulatory documents, validation protocols, agreements and other legal documents.
Establishment of a base of regulatory documents regulating the preparation of recombinant and biological products based on GMP, CLP, GCP, WHO, FDA, ICH.
FreelanceEnglish Translator
Jan. 2018 - Mar. 2020Translation of scientific articles, prescribing information for drug products, clinical trial reports and other documents in the field of biotechnology and pharma.
MyLang schoolEnglish and German Teacher
Mar. 2017 - Aug. 2020Kiev, UkraineTeaching English language on the courses at level range A1 – C1.
Teaching German language on the courses at level range А1-В1.
Creation of education programme.
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