Shubham Lakhangave
Regulatory Affairs Executive @Futura Surgicare Pvt Ltd
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WORK HISTORY
Regulatory Affairs Executive @Futura Surgicare Pvt Ltd
Bengaluru, IN
Medical Devices Regulatory Compliance & Documentation – Manage the preparation, review, submission, and maintenance of regulatory dossiers and records, ensuring ongoing compliance with global standards (ISO 13485, ISO 9001, MDSAP, CE MDR, USFDA, CDSCO) and readiness for audits.
EDUCATION
Nitte University
Master's degree, Pharmaceutical Regulatory Affairs
Rajiv Gandhi University of Health Sciences (RGUHS)
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
ABOUT SHUBHAM LAKHANGAVE
Regulatory Affairs professional with 1 year of hands-on experience in preparing and compiling eCTD dossiers for EU and UK submissions, including Module 1 (SmPC, eAF, product information) and Module 3 (substance and product sections). Skilled in updating product texts to meet the latest QRD templates and supporting US FDA IND submissions. Holds a B.Pharm and M.Pharm in Pharmaceutical Regulatory Affairs from N.G.S.M. Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangalore.
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