Pubblicato su stage4eu il: 19/06/2020
European Medicines Agency, Trainee (Procedures)
EMA - European Medicines Agency
Domenico Scarlattilaan 6, Amsterdam, Paesi Bassi
10 mesi. Inizio: 1 ottobre 2020
1.360 euro mensili
Benefit: contributo alle spese di viaggio
L'offerta scade il 15/07/2020
- perform an analysis of the issues raised during validation of initial MAAs (incl GxP aspects), their correlation with the type of submission, applicant as well as their impact on the start of the procedure. This would serve to update the Agency´s Q&As and published guidance for industry and could serve as basis for an external publication.
- support a project on automatization of regulatory checks during the validation of minor variations using an Assisted Validation System including GMP checks. The trainee will perform an analysis of the changes at post authorisation to develop and improve the functioning of the tool and to include the GMP aspects that are currently not part of the automated checks.
- support the development of a smart form linked to the variations eAF guiding MAHs to include data on QP declarations correctly.
- review of certificates processes in order to streamline for a future implementation of the Regulatory & Scientific Information Management Platform (IRIS).
To be eligible for consideration for this placement, you are required to:
- enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
- possess a university degree in pharmacy/biochemistry/chemistry/biology (minimum of three years or more) that must have been obtained within the last 12 months (July 2019 -July 2020) or be a university student on an Erasmus + or a similar programme or a PhD student.
- a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages
For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.
In addition to the eligibility criteria, a post graduate certification or experience in regulatory affairs would be an advantage.
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