Anilkumar Kondath

About Anilkumar Kondath

A seasoned leader with 25 years of IT & Pharmaceutical domain experience in different facets of software systems and services delivery. Lead multiples programs in consulting, support services and cloud based services to key customers worldwide on a global development and delivery model.Key functional expertise in pharmaceutical research and development domain specifically in Regulatory Affairs & Pharmacovigilance systems and solutions Significant exposure to regulatory guidelines, specifications and data models, compliance requirements like CFR Part 11 and GAMP5. Expertise in Regulatory Operations and associated solutions. Up-to-date with emerging compliance standards like IDMP, eCTD4 etc. on a solution and consulting perspective

Experience

1. Sr Principal Consultant Delivery Lead

   Infosys

   Nov 2012 — Present · Bangalore, IN

   Strategic consulting in life sciences regulatory and pharmacovigilance domains. Drive solution envisioning, techno-functional road maps, validation approaches for efficient realization of project goals. Expertise in drug safety and regulatory systems. Driving scalability and growth of consulting practiceFamiliar with established and upcoming industry requirements and standards like CFR Part11, GAMP, MedDRA, EVMPD, IDMP etc.Driven the implementation and service and support delivery of a large and cloud based regulatory information management system having over ten thousand global users on a fully operational platform model.

Education

• National Institute of Technology Calicut

  B Tech, Electrical Engineering

  1984 — 1988

Skills

• Cross-Functional Team Leadership
• Testing
• Agile Methodologies
• Pl/Sql
• Pre-Sales
• Project Management
• Software Project Management
• IT Strategy
• Enterprise Software
• Sdlc
• Software Development
• Global Delivery
• Integration
• Requirements Analysis
• Validation
• Cloud Computing
• Program Management