Varaprasad Shivakoti

I aim to build a fulfilling career where I can leverage my talents, contribute to organizational growth, and continuously improve through dedication and dynamic engagement. About 10 years of experience in Regulatory Affairs professional with knowledge in, preparation, review, and submission of registration document/dossier for registration in India, and International markets US, HC, EU, China, and ROW countries based on CTD\ACTD format and as per country-specific requirements, Key knowledge areas are as follows; Preparation of dossiers for Pharmaceuticals and Medicinal products for India and International markets. Registration of Pharmaceuticals in India & International markets (ASEAN, EU, US) Good knowledge of US, PMDA,HC,FDA and Europe CMC-eCTD Dossier preparation & submission. Good knowledge of Good Manufacturing Practice (cGMP) & QMS Well-versed with ICH Quality guidelines, e-CTD, CTD, ACTD, NEES, and formats.

• Date of Birth: 05/04/90
• Gender: Male
• Marital Status: Married