Executive/Sr.Executive
About this role
Sun Pharmaceutical Industries Ltd
Key Responsibilities
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Review all data and documents related to product registrations for various health authorities.
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Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
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Prepare responses to deficiency letters received from various agencies.
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Maintain life-cycle / post approval changes for drug product registration dossiers.
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Provide regulatory support to cross functional departments.
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Prepare and submit scientific advice to various health authorities.
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eCTD compilation, verification and submission through electronic gateway
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Review, preparation and submission of annual reports to US FDA
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Review, preparation and submission of post approval supplements to US FDA
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Job Requirements
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Educational Qualification –
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B. Pharma / M. Pharma
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