Company Description
Review and validate the translation to Spanish of documents translated by Area and local translations.
Coordinate the translation to Spanish of the technical, legal and/or clinical support documentation provided by global.
Prepare, review and integrate the files for the submission to the local Health Authority.
Ensure the dossier meets with the local requirements according to the corresponding regulations.
Give a close follow up to internal activities needed for the review & approval of administrative & technical variations.
Develop the local labeling texts ensuring that they meet with local regulations, internal SOP and the reference document provided by the area.
Drive labeling process for creating new or updating previous artworks for the pharmaceutical, biotechnological & biological products, as initiator and/or reviewer.
Ensure that the GMPs and other legal regulatory documents of manufacturing sites are valid during the entir...