Found Description
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 man...
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