Bache Saikrishna

At ClinChoice, I support end-to-end global regulatory submissions across US, EU, and APAC markets, including post-approval variations, CMC supplements, annual reports, and health authority query responses.

I manage product registration records, submission content plans, and CMC change readiness using Veeva Vault RIMS, PDM, PEARL, and TrackWise-based workflows. I've cleansed and validated more than 15,000 regulatory records with 99% accuracy and created ICH Q-aligned QC checklists and SOPs to strengthen dossier quality and audit readiness.

I also build Power BI and Excel dashboards that reduced reporting turnaround by 40% and improved timeline forecasting accuracy by 15%. By turning submission data into real-time KPIs, I help leadership plan CMC readiness across global markets.

My PharmD and clinical pharmacy internship give me a scientific perspective on regulatory work, including pharmacovigilance, ADR documentation, and Module 3 CTD content. I've also trained 10 junior RA Associates on submission handling, RIMS data entry, QC workflows, and submission tracking.