Krishna Ghosh

Background

About Krishna Ghosh

Results –oriented professional with 20 years of management experience in Pharmaceutical, Biotech and Life sciences Industry with proven abilities in establishing and managing Regulatory, Compliance, Manufacturing, Quality systems, QA, QC, teams in Europe, USA and Asia Pacific countries. More than 12 years of experience at FDA in spearheading initiatives in developing new regulations, approving new drugs with cutting edge technologies and implementing new regulatory frameworks for regulating complex drugs and devices. Building highly productive US and global teams with diverse cross -functional capabilities in Biotech, Pharmaceutical and life sciences industry. Expertise in implementing Quality Systems and regulatory strategies for FDA regulated products and International regulatory bodies for product compliance, certifications and FDA approvals. In-depth knowledge in regulatory submissions for 510K, IDE, BLA, ANDA and NDA with broad expertise in solving complex quality problems. In depth knowledge in GMP, GLP, GCP, ICH, MDD, IVDD, TGA, CAMCAS and ISO: 13485 regulations with significant accomplishments in presenting proposals for regulatory approvals. Demonstrated mastery in recruiting top talents, achieving results and driving organizations to successfully deliver regulated products meeting FDA, Australian, Canadian and European regulations.