Sr. Officer

12 hours ago


Navi Mumbai, Maharashtra, India Alkem Laboratories Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

To prepare New, Renewal dossier and variations (Site/ Formula) of MENA and CIS countries and Regulatory knowledge of Guidelines viz, ICH, FDA PICs etc.

To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.

To review of documents for adequacy and accuracy.

To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.

To arrange the samples as per country requirements


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