MIG-2525
CTD Filing specialist
India · September 2, 2022
Hiring Status Unconfirmed
Key responsibilities
Dossier preparation
Preparation of text matter for domestic/ international client and artwork checking as per NDCT rules
Finalize artworks of label in liaison with packaging department.
Responsible for queries for domestic market
Prepare administrative documents required in the dossier.
Prepare documents for license applications, COPP applications.
Procure samples from plant, COAs required for submissions.
Knowledge of CTD filing dossier is must
Desired candidate profile
CTD Filing in CTD format is must
Finished product exp, client exports to different territory
Well versed with regulatory reporting, understanding of ministry of health rules and regulation
Pharma industry exp is must.
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