Job Description

• 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.