Regulatory Affairs Executive

JOB DETAILS
1.Review all data and documents related to product registrations for various health authoritiesCompilation of Drug Master Files

2.Registration Dossiers & Technical Data Packages/OpenParts

3.In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation.

4.Prepare responses to deficiency letters received from various agencies for expeditious approval.

5.Preparation of Regulatory Amendments / Variations for smooth API supplies.

6.Provide regulatory support to cross functional departments.

7.Re-position of regulatory database and compliance to procedures
FUNCTIONAL AREA
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