Regulatory Affairs Officer

3 - 6 years

3.5 - 6.0 Lacs P.A.

Ahmedabad

Posted:3 weeks ago| Platform: Naukri logo

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Skills Required

AndaDossierCMCEurope MarketOSDUSFDARegulatory AffairsFormulationRA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

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