Viresh KUMAR Yarramshetti

Results-driven pharmaceutical executive with 20+ years leading clinical research operations, regulatory compliance, and quality assurance across multinational pharmaceutical and biotechnology organizations. Proven expertise in PK/PD studies, insulin biosimilar trials, and patient-based clinical research with 100% ICH-GCP, FDA, and EMA compliance. Successfully managed 15+ regulatory audits (USFDA, MHRA, ANVISA, NPRA, CDSCO) with zero critical findings.

Strategic leader skilled in cross-functional team management, budget optimization, and operational excellence in GCP/GLP environments.

Deputy General Manager - Operations at Chromo Laboratories India Pvt. Ltd. {Clinical Research and Biosciences division (Formerly part of Cohance Lifesciences)} (2024-04 – Present)

• Direct end-to-end operations of Clinical Research division encompassing Clinical, Bioanalytical, Protocol Writing/Licensing, HR, IT, Stores, and Maintenance departments, ensuring adherence to ICH-GCP and global regulatory standards
• Serve as Management Representative, overseeing quality systems implementation and regulatory compliance across all operational units
• Plan and execute annual operations budget and CAPEX allocation, implementing cost optimization measures resulting in efficient resource utilization
• Successfully managed NPRA (2024) and USFDA (2025), UKMHRA (2026), CDSCO (2026), KAZAKHSTAN (2026) regulatory audits with zero critical findings
• Review protocol feasibility and study designs for complex PK/PD trials, ensuring scientific rigor and regulatory compliance
• Develop and implement comprehensive training programs enhancing staff competency in ICH-GCP and regulatory requirements
• Coordinate with global clients, vendors, consultants, and regulatory bodies to ensure seamless project execution

Clinical Operations Manager (Group Leader) at Wockhardt Research Center (Pharma | Biotech | NDD Division) (2015-05 – 2024-04)

• Led planning and execution of bioequivalence and PK/PD endpoint studies including specialized insulin biosimilar glucose clamp trials, maintaining 100% protocol compliance and zero critical audit findings
• Reviewed and approved study protocols, case report forms (CRFs), and clinical study reports (CSRs) for global regulatory submissions (FDA, EMA, CDSCO, MHRA)
• Managed multiple regulatory audits including USFDA (2019, 2016), UK MHRA (2016), ANVISA (2021), and CDSCO (2023, 2022, 2021, 2019, 2017, 2016) with zero critical observations
• Supervised cross-functional team of 25+ clinical research professionals, conducting performance reviews and developing individual development plans
• Managed clinical section budget planning and CAPEX, optimizing resource allocation and controlling study-related costs
• Authored, reviewed, and implemented SOPs ensuring compliance with ICH-GCP requirements and regulatory standards
• Implemented CDISC standards (SDTM/ADaM) for clinical data management and regulatory submissions
• Established and led CRO qualification program, conducting audits and managing vendor relationships for outsourced studies

Lead Study Coordinator - Clinical Operations at Apotex Research Pvt. Ltd. (2009-08 – 2015-04)

• Executed end-to-end project management for bioequivalence studies supporting ANDA submissions to USFDA, EMA, Health Canada, DCGI, ANVISA, and UK MHRA
• Served as Global Deficiency Response Team (DRS) member, resolving complex regulatory queries from multiple global health authorities
• Prepared and reviewed case report forms (CRFs) and clinical study reports (CSRs) ensuring quality, accuracy, and regulatory compliance
• Managed DOCUBRIDGE electronic submission system for regulatory filing of clinical documentation
• Successfully handled USFDA, UK MHRA, EMA, and CDSCO regulatory audits with compliant outcomes

Senior Executive - Clinical Research & Drug Regulatory Affairs at Famy Care Ltd. (2008-03 – 2009-07)

• Established clinical affairs department systems and procedures as initial team member, implementing GCP-compliant processes
• Led CRO identification, qualification audits, and vendor selection for national and international clinical studies
• Prepared Module 2 (Clinical Overview), Module 4 (Nonclinical Study Reports), and Module 5 (Clinical Study Reports) for CTD submissions
• Collaborated with external consultants on IVIVC assessments and regulatory strategy development

Clinical Research Associate - Clinical Operations at Wellquest Clinical Research (Piramal Healthcare) (2007-01 – 2008-03)

Clinical Research Associate - Clinical Operations at Bioserve Clinical Research Pvt. Ltd. (2005-01 – 2006-12)

Master of Business Administration (MBA) in Health Care Management – Sikkim Manipal University

Master of Pharmacy (M.Pharm) in Pharmacology – Jawaharlal Nehru Technological University

Bachelor of Pharmacy (B.Pharm) – Jawaharlal Nehru Technological University