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Bhargava Phytolab logo
Senior Executive Bhargava Phytolab

3.0 - 5.0 years

1 - 3 Lacs

bhiwadi, delhi / ncr

Work from Office

Role & responsibilities Preparation of CTD/ACTD & Country specific Dossiers Handling queries obtained from different regulatory agencies and customers across the world. Compilation, preparation and review of Technical Package of APIs. Compliance to audits of regulatory bodies especially USFDA and EU. Generation of documents from, Production, QC and QA of newly developed products Responsible for record keeping and to ensure correctness of records pertaining to department. • Knowledge of ICH Guidelines to prepare documents accordingly Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary document...

Posted 1 month ago

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