Regulatory Affairs-Manager

4 days ago


Nagpur India ZIM LABORATORIES LIMITED Full time

Job Description JOB Responsibility - Preparation, review & submission of ectd/ctd dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products - Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO - Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products - Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products - Documents review QQF, Change control, specifications, Commercial specifications, artworks - Process Validation Protocols & Report, Hold time study protocol & report, NDMA reports, Photo stability reports, Elemental reports, Risk assessment, Out of Specification. - Co-ordination with external & internal clients. - Updation and maintenance of database of dossier status. - Fulfil requirement for site registration and GMP clearance/approvals


  • Regulatory Affairs

    3 weeks ago


    Nagpur, India Select Source International Full time

    Regulatory Affairs Assistant Manager professional: Core Keywords Regulatory Affairs (RA) Assistant Manager Regulatory Affairs Dossier & Submission Expertise CTD / ACTD / eCTD dossier preparation Module 3, Module 5 Lifecycle management (PLCM) Post-approval variations / renewals Regulatory submissions & query responses Client due diligence Ministry of Health...

  • Regulatory Affairs

    5 days ago


    Nagpur, Maharashtra, India Select Source International Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Regulatory Affairs Assistant Manager professional:Core KeywordsRegulatory Affairs (RA)Assistant Manager Regulatory AffairsDossier & Submission ExpertiseCTD / ACTD / eCTD dossier preparationModule 3, Module 5Lifecycle management (PLCM)Post-approval variations / renewalsRegulatory submissions & query responsesClient due diligenceMinistry of Health (MOH)...

  • Regulatory Affairs

    1 week ago


    India Sunrise Remedies Full time

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  • india Frisch Medical Devices PVT LTD Full time

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