Senior Regulatory Officer - Pharmaceutical Industry - S G Highway, Ahm

4 - 9 years

1.0 - 6.0 Lacs P.A.

Ahmedabad

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Dossier PreparationAhmedabadCTDArtworkCOPPRegulatory AffairsProduct PermissionACTD

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities - Preparation of CTD and ACTD Dossiers. - Should have knowledge about Southeast Asian guidelines for Dossier preparation. - Preparation and Reviewing Artwork - Coordination with manufacturers regarding quality documents. - Reviewing quality documents - Should have sound knowledge of FDA related work. (Product Permission, COPP, Mfg. License, GMP certificate). - Prepare and submit query response within timeline.

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