Executive

Year Vadodara, Gujarat, India

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Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)Grade - G12A/G11BEducation - B.Pharm / M. PharmExperience - 4 to 6 yearsLocation - R&D - Baroda:

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

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