▷ 15h Left Manager

4 weeks ago


Vadodara India SUN PHARMA Full time

Job Description Job Description - Preparation of registration strategy for various health authorities like Brazil and other Latin American countries i.e. Peru, Ecuador, Colombia, Panama - Adequate understanding on Brazil guidance and filing of new product and post approval changes - Review of documents related to product registration and dossier submission leading to faster approval - Prepare response to deficiency letter received from various agencies - Maintain life-cycle / post approval changes for drug product registration dossiers including timely circulation of approval information - Provide regulatory support to cross functional department - Adequate assessment of change control as per regulatory guidance - Prepare and submit scientific advice to various health authorities - Compilation, verification and submission through electronic gateway



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