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Coral Drugs logo
Executive / Officer - Regulatory Affairs Coral Drugs

3.0 - 7.0 years

0 Lacs

haryana

On-site

Role Overview: As a Regulatory Affairs Specialist, you will be primarily responsible for the compilation, preparation, and review of Drug Master Files (DMFs) for various markets such as US, Europe, Canada, and ROW in specified eCTD, NeeS, or CTD formats. Your role will also involve setting specifications for API process development and having knowledge of litigation related to Drugs and Cosmetics Act. Ensuring compliance with audits from regulatory bodies like USFDA and EU, as well as generating documents from departments like R&D, Production, QC, and QA for newly developed API's will be crucial. Key Responsibilities: - Compiling, preparing, and reviewing DMFs for different regions - Filing ...

Posted 2 weeks ago

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