Executive

Cadila Pharmaceuticals Limited

0 years

0 Lacs

Dholka Gujarat India

Posted:1 week ago| Platform:

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Skills Required

test development reports stability controls qc marketing query reporting

Work Mode

On-site

Job Type

Full Time

Job Description

Compilation, review and submission of registration dossiers in the regions of South East Asia
Handling of regulatory queries/deficiencies across all the South East Asia countries
Submission of Supplements/Variations across all the South East Asia countries
Review of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols etc. and Review and approval of Change Controls & Deviations
Ensure availability of current guidelines for South East Asia
Establish co-ordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within period
Submission of various original documents for notarization, chamberization and legalization, which forms an important part of dossier
Arrangement of Samples, Packing Material, Impurities, Reference Standards as per MOH requirement
Preparation of COPP’s (Certificate of Pharmaceutical Product) and FSC submit to Local FDA approvals
Any other assignments as specified by the reporting authority from time to time

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