Srikumar M Raja, Phd, Msrc, Cssgb Email and Phone Number

PROFESSIONAL SUMMARY: • Regulatory Affairs professional with experience with regulatory submissions (eCTD & Non eCTD formats) to US FDA, Health Canada, UK MHRA and EU submissions, including INDs/CTAs, IND/CTA amendments, Annual reports/DSURs, Safety Reports, IDEs related to drugs, devices, and combination products.• Leading, managing, training, and mentoring of Regulatory Affairs Team.• Served as a Sponsor representative and primary contact with the FDA for commercial and non-commercial IND/IDE submissions.• Extensive knowledge of US FDA regulations, EU CTR, Health Canada Guidance and International Council for Harmonization (ICH) guidelines to identify and interpret regulations, guidelines, and pertinent regulatory information to support a clinical development program.• Experience in initial registration, maintenance and final results posting in Clinicaltrials.gov, EU Clinical Trials Registry and other National and International trial registries to meet regulatory requirements for trial transparency.• Experienced in writing and reviewing clinical trial protocols, Informed Consent Forms, and pertinent materials for Regulatory Authorities and Institutional Review Board (IRB)/Ethics Commission submissions.• Served as a scientific IRB review panel member with Northwestern University Institutional Review Board.• Experience in site management of all Study Startup activities from site-selection through study activation. • Experienced in conducting internal audits and managing site regulatory audits and inspections.• Quality professional with Certified Six Sigma Green Belt (American Society for Quality).• Experienced in Identifying new areas of business growth in CRO Regulatory Affairs.• Active participant and contributor to organizational process improvement initiatives