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Job Location | Ahmedabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Recruitment Services |
Functional Area | General / Other Software |
EmploymentType | Full-time |
M.Sc/M.Pharm/PhD with more than 10-12 Yearsexperience in managing teamHandling regulatory affairs activities for API business is mustFiling adequate and zero deficient DMF in all MarketsReview of compiled DMFs (in eCTD or NeeS formatRequired Candidate profileThorough knowledge of ICH guidelinesExpertise in Life Cycle Management of DMF changes,enrolling,monitoring and assessmentUpdate / train the Regulatory Sciences team for SCM-API on Regulatory guidelinesClosely working with ADL and QA,
Keyskills :
capa qms risk analysislife cycle team handlingregulatory affairs regulatory guideli