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Ra Executive

2.00 to 4.00 Years   Ahmedabad   27 Mar, 2024
Shamisha Resources Management LLP
Job LocationAhmedabad
EducationNot Mentioned
SalaryRs 2.0 - 5 Lakh/Yr
IndustryPharma / Biotech
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

    Looking For Regulatory Affairs.
    • Preparation and submission of product dossiers as per CTD (Common Technical Documents), ACTD, ROW countries as per guidelines.
    • Preparation and submission of renewal documents/renewal dossiers/ variations/responding to queries raised by Ministry of Health, International agencies as well as the various customers.
    • Involved in co-ordination with Plant, R&D and QA-QC
    • Department for preparation and receiving & reviewing of technical
    • Documents such as DMF, Stability data, etc. and arranging for the samples required for submission along with the product dossiers.
    • Handling (receipt and responding) product related regulatory or customer queries.
    • Following the Standard Operating Procedure for document
    • handling and maintenance.
    • Preparing and sending out project progress reports and raising
    • early alarms on issues that might delay approvals.
    • Representing the regulatory function during cGMP and Safety inspections.
    • Review of printed packing materials and pack insert.
    • Review of quality documents such as Finished product specification, raw material specifications, Standard test procedure, Certificate of analysis of finished product result.
    • Review of analytical method validation and process validation.
    • Review of process validation protocol, report, BMR and BPR.

Keyskills :
dossier preparationctdactd

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