Amit Sambhare

Background

About Amit Sambhare

A competent pharma regulatory affairs professional having around 12+ years of diversified experience in the Pharmaceutical industry. Major area of expertise are: Drug Regulatory Affairs (CMC) for Europe, Canada, US DCP and National filing in EU, ANDA filing in US and ANDS in Canada, Post Approval Changes, Product Life Cycle Management especially for Solid Oral Dosage Forms. Handling a team and provide appropriate guidance to peers for the completion of project within timeline. Extensive experience in handling regulatory requirements through the product life cycle both in Preapproval as well as post approval phases with core focus in CMC. Excellent Communication, Inter Personal and Project management skills with a strong technical and functional background. I am a key member to provide regulatory guidance for Pre-approval and post-approval requirements from RA perspective and have contributed significantly to strategic improvements in product quality through its life cycle.