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Regulatory Affairs Associate

2.00 to 3.00 Years   Bangalore   16 Nov, 2020
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD,R&D / Product Design
EmploymentTypeFull-time

Job Description

Work on post approval CMC activities. Licence Renewals, CMC and safety variations, MAA submissions, withdrawals etcQualificationsExperienced in CMC post approval submissions for EU, Australia, Canada and other RoW countries. Should have hands on experience liasing with various health authorities. Exposure to Document Management System(DMS) and Regulatory Information Management System(RIMS) is an added advantage.,

Keyskills :
soprenewalsmanagementinformation managementdcgidocument managementwithdrawalsclinical trialsapacdocumentationedrmsdocument captureliasingiprodocument imagingregulatorycmc

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