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Ronak Exim logo

Executive / Sr. Executive - Regulatory Affairs

1 - 5 years

3 - 4 Lacs

Vadodara

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Regulatory Affairs Management Product development manufacturing process process validations Dossier preparation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline. Technical documents like Raw Material and finished products specification, manufacturing process, Product development report, stability reports, process validations Required Candidate profile Analytical method validation review as per the ICH guideline. Drug Master File review Technical query response to the various regulatory authorities. Dosage – Oral solid, Liquid, Injectable

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Ronak Exim
Ronak Exim
www.ronakexim.com

Export/Import, Manufacturing

Mumbai

50-200 Employees

6 Jobs

    Key People

  • Ronak Shah

    Managing Director

  • Vijay Mehta

    Business Development Manager

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