Alexandra Ali Email and Phone Number

Registration and regulatory specific activities within the EU legislation and related guidelines and also within the frame of the national provisions.

Between January-May 2017 I'm detached for external project in London(UK) for Sumi Agro Europe.Specific registration activity with regards to the formulated products.

-manages Biological Dossiers and registration process according protocols;-submit and follow up documents and dossier related to the registration process;-build and maintain excellent working relations with regulatory authorities and other key influencers, in order to develop and/or maintain a favorable regulatory environment for the product portfolio;-identify potential product issues and prepare pro-active measures, communication activities and stewardship programs-create and update labels according to EC and national legislation.

-evaluate, prepare and submit drug registration applications and follow through the application during the evaluation phase to achieve a favourable outcome;-assist in the preparation of applications for registration of new products, variations to marketed products;-assist with responses to deficiency letters and other requests for data from regulatory agencies;-maintain registration of currently approved products;-marketing and other department regulatory queries;-review labelling, product information, consumer medicine information for compliance with relevant regulations and codes.

-KRKA-organization meeting sites;-KRKA-management relationship with travel agencies;-promotional materials, supervision and acceptance of a qualitatively and quantitatively, according to the invoice;-ensure the correct use and supervision of the graphic image of the company in the market;-KRKA-brokering sponsorships made to doctors and pharmacists for national and international congresses - accommodation, taxes, transportation, preparation of documentation for each invoice explanatory;-preparing, coordinating and implementing the marketing and other corporate activities, primarily for professional audiences but also for the general public;-cooperation in the development, implementation and coordination of activities focused on marketing of the product and the image of the organization to different audiences.

-preparation of the dossiers that needed to be applied to the competent authorities;-site communication;-maintenance and archive of the documents related to clinical trials;-assistance in creation and registration of speaker contracts;-organizing and preparation for investigator meetings;-article translations;-technical and logistic assistance for clinical trials, medical department and EU markets.