Experience

  • Junior Regulatory Affairs Specialist

    at ADAMED PHARMA S.A.

    October 2018 - at Present

    Województwo Mazowieckie

    Contribute to success of drug development (pre-marketing and post-marketing stages); submission of dossiers to National Authorities in terms of preparing administrative documentation regarding marketing authorisations, renewals, post-authorisation variations in different procedures (NP, DCP, MRP, RUP) in CTD and eCTD format; preparation of product information ensuring that quality standards are met according to QRD template; verification of artworks of medicinal products; contact with the Authorities, verification of Market and Data Exclusiveness for referential products, preparation of prenomination for new registrations in European markets; participation in the development of a new system that monitors the procedures status.

  • Junior Scientific Information Specialist

    at ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A.

    June 2018 - October 2018

    Województwo Mazowieckie

    Preparation and verification of Product Information for new registration and post-authorization variation procedures of medicinal products; verification of the correctness of packaging and leaflet artworks; preparation of readability test reports and bridging reports; European market insight at an angle of new medicinal product registration possibility; scientific literature review conduction.

  • Junior Regulatory Affairs Specialist

    at SCIENCEPHARMA SP. Z O.O. SP. K.

    September 2017 - May 2018

    Województwo Mazowieckie

    Supporting process of dossier submission to National Authorities in terms of preparing administrative documentation (regarding marketing authorisations, renewals, post-authorisation variations, grouping variations etc.) in different procedures (NA, DCP, MRP, CEN); preparing comprehensible, user-friendly product information leaflets and labels ensuring that quality standards are met according to QRD template; verification of artworks for medicinal products; preparing translations of sRMP, PIL, SmPC, Authorities decisions; ad hoc activities.

Education

  • MASTERS DEGREE

    at Jagiellonian University Collegium Medicum

    2013 - 2015 (2 years) Województwo Małopolskie

  • BACHELORS DEGREE

    at Jagiellonian University Collegium Medicum

    2010 - 2013 (3 years) Województwo Małopolskie

Languages

  • English Native

Hives