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For Employers

Manager

Cadila Pharmaceuticals

10 - 15 years

5 - 10 Lacs

india gujarat

Posted:1 hour ago| Platform:

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Skills Required

international sales ectd pharmaceutical regulatory anda dossier control ent ra ich change control marketing ctd latam portfolio international marketing product development regulatory affairs drug regulatory affairs product portfolio row europe reporting actd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Planning of Dossier and maintaining the client’s product portfolio, update guideline and renewal calendar for MENA region. Compilation, review and submission of registration dossiers in the regions of, MENA, South Africa, Latin America Region. Handling of regulatory queries/deficiencies across all the South Africa, MENA, Latin America (Region VI) countries. Submission of Supplements/Variations across all the MENA countries, South Africa, Latin America region also. Review of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols etc. and initiation of Change Controls & Deviations. Ensure availability of current guidelines for Region VI (South Africa, MENA, LATAM,). Arrangement of Samples, Packing Material, Impurities, Reference Standards as per MOH requirement. Any other assignments as specified by the reporting authority from time to time To maintain country wise and product wise registration status for Region VI (South Africa, MENA, LATAM). Creation and Maintenance of Regulatory Database for all the submissions. Establish co-ordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. Preparation of COPP’s (Certificate of Pharmaceutical Product) and FSC for submission to FDA approvals.Submission of various original documents for notarization, chamberization and legalization which forms an important part of the dossier.

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Cadila Pharmaceuticals

Pharmaceuticals

Ahmedabad

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Manager