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Senior Regulatory Affairs Consultant

15.00 to 17.00 Years   Bangalore   14 Nov, 2022
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Reviewing/Preparation of the clinical regulatory documents for Innovator products (new filings/hybrid filings) listed below, not limited to:
    • Briefing documents/meeting packages
    • General investigation Plan
    • Investigator Brochures
    • CTD modules such as Module 2.5 (Clinical overview), Module 2.7(Clinical summary and tabulations including Summary of Safety (ISS), summary of Efficacy (ISE)
    Preparing/reviewing responses to heath authority queriesEducational backgroundMasters in pharmacy/PhD/BDS/MBBS, advanced degree preferredAround 15 years of overall experience in Industry/regulatory domain with knowledge Biologics/Biosimilars,

Keyskills :
new drug applicationtargeted therapieswritingclinicaloncologyauthoring

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