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Regulatory Affairs Officer

3.00 to 5.00 Years   Ahmedabad   24 Feb, 2025
United HR Solutions Pvt Ltd
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    Clients Company Profile:Our client is into Import & Export of Pharmaceutical / Medical Device Company (European MNC). The company provides tailored intelligent healthcare solutions based on the latest professional insights, and on decades of experience in Africa.They are head quatered in Europe, having repacking unit in Gandhidham and Corporate office in AhmedabadPosition:Regulatory Affairs OfficerJob Location:Bodakdev (Ahmedabad)Reports To:Regulatory ManagerJob Profile:The position would be responsible for :1. Request, follow-ups and obtain product dossier from the manufacturer where applicable.2. Assess and report deficiencies to the manufacturer and recollect documentation as appropriate, also to escalate internally and report to manager.3. Prepare and submit registration dossiers as per CTD/Country specific requirement with layout review for submission.4. Completion and ensure dossiers submission in targeted timeline.5. Dispatch of registration dossiers to the National Drug Regulatory Authorities (NDRA)/agents as applicable.6. Actively finding solutions on queries/feedback from NDRA/agent for suppliers having difficulties in meeting the requirement.7. Request and follow-up on samples required for submission.8. Status updates on connect Registration and NDRA overview.9. Coordinate with Companys agents and Country Managers on handling regulatory submission and update on country guidelines. Process the payment for dossier submission.10. Review of technical documents/dossiers as per country requirement to ensure quality submission with zero query.11. Response to query received from NDRA on priority.12. Smooth initiation of renewal/retention process for different countries and ensure timely submission.13. Filing of variation in different countries as applicable14. Ensure that database is maintained updated reflecting actual activity, organize meetings and report to manager.15. Any other duties or assignments as requested by the managerDesired Candidate Profile:Qualification: B.Pharm / M.PharmWork Experience: 3-5 years of experience in regulatory functions from pharmaceutical organizations.
    • Knowledge of ROW market and regulatory experience in medical devices is preferred.
    • Updated on various regulatory guidelines on WHO, EU and ICH.
    • Ability to maintain a positive attitude under pressure and in stressful situations.
    • Good administrative and communication skills.
    • Should be able to work within a team.
    • Should be well structured and systematic.
    • Languages: Good proficiency in English
    Contact Person:Neha SharmaEmail : hidden_emailMobile No. : 91 hidden_mobile

Keyskills :
regulatory affairsctddossier registrationproduct dossier

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