Regulatory Affairs Executive

2 - 5 years

2.0 - 5.0 Lacs P.A.

Pune

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Drug Regulatory AffairsCTDDossier PreparationRow MarketActdSubmissionDossierRowEctd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Ensure that submission of CTD, eCTD, aCTD dossiers. Meet all regulatory requirements. Participate in contacting competent authorities for respective products. Preparation of regulatory submissions (Dossier, Variations) to authorities. Required Candidate profile Should have deep knowledge of Preparation and submission CTD, eCTD and ACTD Dossiers to ROW drug regulatory authorities. Should be able to handle queries, Artworks check, regulatory planning.

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