nilesh thever

Experienced Professional with multiple roles and 10+ years of experience in areas of medicinal research, Regulatory Information Management, Operations, eTMF, Laboratory information management (LIMS), Risk & Compliance in service industry and Information technology for Life Sciences & Health care domains.
Aim is to reach the Business Platform by utilizing my vital skills and thinking capacity positioning the organization I work into counting industries.

Current Engagements: Work on new technologies and data integration to help clients in different phases of discovery, design, manufacture and register regulatory evidence for medicines and vaccines. Currently associated with a LIMS project which seeks challenging assignments to improve Business agility, identify & maintain IT compliance and control gaps by implementing solutions. Ensuring team keeps going forward and in right direction.

 Previous Engagements: Liaise with GCM and submitters to generate data driven responses, provide inputs and review submission documents to them to maintain compliance and ensure the committee submit appropriate responses to questions put by Regulatory Agencies before final archival of documents

Master of Science: Organic Chemistry 

Certifications: 

Business Analysis Foundations 

Lean Six Sigma Green Belt 

Certified SAFe® 6 Agilist

MasterCraft DevPlus Team Edition Scrum  

User Experience Design Thinking Intermediate E1