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    REGISTRATION SPECIALIST (DRUG REGISTRATION DEPARTMENT)
    Regions:
    Kiev;

    Today KUSUM is in the TOP-10 leaders of the Ukrainian pharmaceutical market. For 25 years of our activity, we have done everything possible to constantly offer only high quality, effective and safe medicinal products.

    KUSUM is a special microclimate. We provide each employee with health insurance, a corporate gym and a medical room within the office; every day our chefs prepare fresh meals. We also offer many other things to take care of the comfort and health of our employees.

    We regularly and actively work to improve our activities. KUSUM is not just a job, it is a way of life!

    For this position, we would value:

    • Higher pharmaceutical/chemical education
    • Knowledge of the requirements of the legislation on the registration of medicinal products
    • Knowledge of modern guidelines on quality, safety, efficacy of medicines, in particular:
    • confirmation of compliance of production sites and processes with GMP requirements
    • pharmaceutical development
    • in vivo/in vitro equivalence assessments
    • quality of active ingredients, excipients and packaging
    • specifications of medicines, control methods
    • validation of technological processes
    • study of the stability of substances and drugs
    • Ability to work with technical and scientific pharmaceutical documentation
    • Knowledge of English at the Intermediate level

    Main responsibilities:

    • Compilation of dossiers for registration of medicinal products in the CTD format
    • Submission of dossiers and samples to regulatory authorities, receipt of inquiries and approved documents
    • Interaction with employees of state expert organizations for the purpose of drug registration
    • Monitoring and ensuring the registration process in regulatory authorities. Preparation of responses to requests of regulatory authorities 
    • Documented dossier management
    • Interaction with the departments of pharmaceutical development, quality assurance, quality control, as well as other regulatory agencies

    We offer:

    • official employment from the first day according to the Labor Code of Ukraine;
    • timely salary and planned salary growth;
    • corporate events;
    • work schedule: full time, Monday–Friday 09.00–18.00.

    We do not consider remote collaboration!

    • our new and modern office is located on the Left Bank in the DVRZ area (the nearest station is M. Chernihivska);
    • taking care of your health, medical insurance. Preference for candidates vaccinated against COVID-2019

    To start working at KUSUM, please send your CV specifying your financial expectations.