About the Role
**Job Description:**
+ Review all data and documents related to product registrations for various health authorities.
+ Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
+ Prepare responses to deficiency letters received from various agencies.
+ Maintain life-cycle / post approval changes for drug product registration dossiers.
+ Provide regulatory support to cross functional departments.
+ Prepare and submit scientific advice to various health authorities.
+ eCTD compilation, verification and submission through electronic gateway
+ Review, preparation and submission of annual reports to US FDA
+ Review, preparation and submission of post approval supplements to US FDA
+ Reviewing of the plant change control and established the variation strategy for submission
+ Review of query response prepared and compiled by regulatory associates
+ Review ...
+ Review all data and documents related to product registrations for various health authorities.
+ Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
+ Prepare responses to deficiency letters received from various agencies.
+ Maintain life-cycle / post approval changes for drug product registration dossiers.
+ Provide regulatory support to cross functional departments.
+ Prepare and submit scientific advice to various health authorities.
+ eCTD compilation, verification and submission through electronic gateway
+ Review, preparation and submission of annual reports to US FDA
+ Review, preparation and submission of post approval supplements to US FDA
+ Reviewing of the plant change control and established the variation strategy for submission
+ Review of query response prepared and compiled by regulatory associates
+ Review ...
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