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IRA (US Market)

2.00 to 5.00 Years   Ahmedabad   26 Sep, 2023
Cadila Healthcare Ltd
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    • Preparation of Supplements for post approval changes of ANDA for injectable and solid oral dosage form (i.e. PAS, CBE 30 and CBE and ensure that it is meeting current FDA thinking)
    • Ensured to have post approval compliance at risk based assessment. (i.e., determining and Evaluating appropriate fling category.)
    • Review of all the technical documents required for post approval changes for injectable and solid oral dosage form
    • Ensuring all compiled post approvals are in compliance with current FDA thinking and expectations to minimize the deficiencies.
    • Preparation of Annual reports for all approved products as per annual report submission time line for injectable and solid oral dosage form.
    • To track all changes from time to time in the annual report period of approved products and ensure submission of all changes to FDA with detailed change histories
    • Evaluation of Change control / deviation and review of technical documents in its support for injectable and solid oral dosage form
    • Review of BMRs, BPRs, Specifications Method Validation Protocols and reports.
    • Prepared and review of Approval Package
    • To co-ordinate deficiency meeting for response and action plan with CFTs.
    ,

Keyskills :
change controlannual reportsmethod validationriskandacontrolapprovalsprotocolscompliancevalidationevaluationinjectable

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