Phone: +91 8871349795
Email: gyanendra199233@gmail.com
Location: Bangalore, India
LinkedIn: www.linkedin.com/in/gyanendracmc/
Professional Overview
Strategic regulatory professional with 9+ years of experience across pharmaceutical regulatory compliance, CMC strategy, and digital transformation. Proven track record leading global initiatives in regulatory operations optimization, RIM/eCTD implementation, and AI-enabled regulatory intelligence.
Currently pursuing an MBA in Artificial Intelligence to drive next-generation RegTech and consulting solutions for pharma/biotech clients. Specializing in bridging the gap between regulatory science and technology innovation.
Core Competencies
Regulatory Strategy
CMC Strategy, GAP Analysis, IMPD-to-US IND Conversion, Regulatory Transformation Planning
Submissions & Compliance
IND/BLA/ANDA Submissions, FDA/EMA/ANVISA Filings, Post-Approval Changes, Lifecycle Management
Digital Transformation
AI-Driven Process Automation, RIM Implementation, eCTD Authoring, Regulatory Intelligence
Technology Platforms
Veeva Vault RIM, Documentum, CAPTIS AI Platform, DocuBridge, TrackWise, Cortellis
Team Leadership
Cross-functional Management, Training & Capability Building, SOP Development, Consulting
AI & Data Analytics
Machine Learning Applications, Predictive Analytics, Automated Literature Screening, HEOR Support
Current Focus
Regulatory Transformation
Optimizing CMC submission processes and regulatory operations for efficiency and compliance
AI-Enabled Solutions
Implementing AI and automation in regulatory workflows and intelligence systems
Life Sciences Consulting
Consulting opportunities in regulatory technology and HEOR/SLR services