Based on the experience gained through the years of hard work, technical skills and client communications, I can handle extreme pressure with ease. Vison oriented and organized documentation. Skilled professional in time management with work life balance. A result oriented professional with nearly 13 years of experience in Regulatory Affairs, Clinical Trials, Research & Development. Prepared about 100+ dossiers for solid oral dosage forms and clinical report for about 25 products. Lead and implement all regional CMC submission activities (planning, review, co-ordination, submission) for assigned projects/products, while applying the global strategy into regional submissions. Experience of handling queries, post approval changes and communicating with regulatory authorities for successful completion of projects & fulfilling commitments. Strong organizer & motivator with a successful track record during health agency’s inspections and technical audits by customers and ministry of health.