Bhagyalakshmi Iyer

Assistant Manager @Genpact

Mumbai, MH, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2019 — Present

Assistant Manager @Genpact

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Mumbai, IN

Preparation of high quality dossiers and documentation for registration of various pharma formulations for export to ROW markets(regulated and semi-regulated - CIS, SEA, LATAM, Middle East, Franko-Africa) in ACTD, CTD formats as per country requirement.Daily follow up with R&D and manufacturing plant for data required for preparation of Dossier.Support in writing responses to HA queries in support of Renewals.Regulatory Database maintenance.Compilance with ICH guidelines. Team ManagementProject ManagementMetrics AnalysisProcess Improvements

EDUCATION

2010 — 2012

Lokmanya Tilak Municipal Medical College,Sion,Mumbai

Master of Science (MSc)

2007 — 2010

SIES College of Arts,Science and Commerce,Sion,Mumbai

Bachelor of Science (B.Sc.)

SKILLS

Team LeadershipEmaLife SciencesSponsor Study Record (Ssr)Regulatory AffairsPharmaceutical IndustrySopEdcDocumentationEmployee RelationsCtmsIch-GcpQuality ControlTrainingOncologyTeamworkTeam ManagementRimsClinical ResearchPerformance ManagementProject ManagementClinical TrialsRegulatory SubmissionsMicrosoft OfficeU.s. Title 21 Cfr Part 11 RegulationMicrosoft ExcelHealthcare

ABOUT BHAGYALAKSHMI IYER

A thorough professional with 13 years of experience in the Pharmaceutical industry with…

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Bhagyalakshmi Iyer — Assistant Manager at Genpact in Mumbai, MH, IN | Unifers