Saikrishna Bache

About Saikrishna Bache

Strategic data professional with 2+ years of end‑to‑end experience in regulatory affairs, clinical research, and healthcare analytics. I blend deep pharmaceutical knowledge with advanced analytics to transform complex regulatory and clinical datasets into actionable, decision‑ready insights that accelerate product development and ensure compliance across global markets.At ClinChoice, I engineered a suite of Power BI and Excel dashboards that cut reporting turnaround time by 40% and delivered real‑time KPI visibility to senior leadership. By cleansing and validating regulatory records, I built audit‑ready databases achieving 99% data accuracy, while systematic QC checklists reduced manual follow‑up effort by 25%. My data‑driven trend analyses enabled a 15% improvement in submission timeline forecasting and supported health‑authority query responses across US, EU, and APAC markets.I thrive in cross‑functional, multicultural environments, partnering with clinical, regulatory, and commercial teams to align data strategies with business objectives. I have led requirement‑gathering workshops, mentored junior analysts, and authored SOPs that standardized data‑quality processes globally. My collaborative leadership style emphasizes transparency, continuous learning, and empowering teams to deliver high‑impact analytics under tight regulatory timelines.Looking ahead, I aim to deepen my expertise at the intersection of AI‑enabled analytics and regulatory science, driving predictive insights that pre‑empt compliance risks and optimize clinical trial operations. I am eager to contribute to forward‑thinking organizations where data excellence fuels innovation, patient safety, and market success.If you are seeking a results‑focused analytics leader who can bridge regulatory rigor with cutting‑edge data visualization, let’s connect to explore how we can accelerate your organization’s compliance and commercial goals.

Experience

1. Regulatory Affairs Associate

   ClinChoice

   Jun 2024 — Present

   As a Regulatory Affairs Associate, I work with regulatory data to support smarter decision-making. I collaborate with teams to manage data systems, build dashboards, and create reports that support compliance and submissions. I enjoy turning complex data into clear insights that help streamline processes and drive efficiency.Led requirements elicitation for CMC changes across US/EU/APAC markets, improving submission readiness for multiple product events.Designed and automated Power BI and Excel dashboards, reducing reporting turnaround time by 40% and providing real‑time KPI visibility to senior leadership.Cleaned and validated regulatory records, establishing audit‑ready databases with 99% data accuracy.Performed statistical trend analyses that identified data gaps, cutting manual follow‑up effort by 25% and supporting health‑authority response strategies.Developed and maintained QC checklists and SOPs, standardizing data consistency across global submissions.Presented analytical findings and strategic recommendations to senior management via PowerPoint decks, influencing key decision‑making.Conducted stakeholder interviews with clinical and regulatory experts to align data collection and dashboard design with business needs.Implemented basic forecasting models for submission timelines, improving planning accuracy by 15%.Created internal survey questionnaires to capture stakeholder feedback on data‑quality processes, driving continuous‑improvement initiatives.Trained and mentored 3 junior analysts, boosting team productivity by 20% and enhancing knowledge transfer.

Education

• Sri Chaitanya Junior College, Vijayawada

  Intermediate , science

• Rajiv Gandhi University of Health Sciences

  Doctor of Pharmacy - PharmD, Pharmacology, Therapeutics and Clinical Research

• MJPBCWAPRS SCHOOL, LEPAKSHI

  HIGH SCHOOL, SSC

• HKES's Teaching and General Hospital, Gulbarga

  Internship, General Medicine, General Surgery, Orthopaedics and Pediatrics