Sainath Gadam

Senior Manager Regulatory Affairs @Lupin

Nagpur, MH, IN

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Apr 2023 — Present

Senior Manager Regulatory Affairs @Lupin

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Nagpur, IN

EDUCATION

2009 — 2010

Indian institue of business management

Master of Business Administration (MBA), Operations Management and Supervision

2016 — 2018

Birla Institute of Technology and Science, Pilani

M. Tech. - Pharmaceutical Operation Management, Operations Management and Supervision

2001 — 2004

Doctor Babasaheb Ambedkar Marathwada University

B-pharmacy, Pharmacy

SKILLS

Risk AssessmentRegulatory AffairsQuality AssuranceTechnology TransferQuality SystemV&VQualification and ValidationGmpComplaint ManagementAndaValidationVendor AuditStandard Operating Procedure (Sop)PharmaceuticsQuality ManagementCapaCleaning ValidationTrainingFailure AnalysisInvestigationSix SigmaPharmaceutical IndustrySopFda

ABOUT SAINATH GADAM

Working in Regulatory Affairs having about 13 years of relavent experience, dealt with various international regulatory audits in pharmaceutical profession.Specialties: Astute professional in ANDA/MA application to USFDA/MHRA/TGA/WHO.Quality assurance in Pharmaceutical field. Qualification / Validation, Quality Management system, Auditing raw material Manufacturer(National / International)

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