Executive

Year Vadodara, Gujarat, India

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Compilation and review of new submission in eCTD format for Non-oral and Oral product. For US/EU/AUS market
Exclusively Evaluate, Discuss and Finalize the Deficiency response for US Market US/EU/AUS market.
Review of formulation at the initial stage of development as per current guidance.
Review of Analytical documents, PDR, Mfg document at the initial stage and during development as per current guidance.
Assessment of prototype document & DMF for dossier perspective.
Co-ordination with cross functional team for development of formulation and execution of batches and provide regulatory support as per regulatory guidance.
Provide expert to CFTs related to Regulatory requirements based on FDA\'s recent published guidance and recent trend of deficiency received from the FDA.
Actively participate for deficiency response and eCTD perspective.

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