Ankitha nayak

Led end-to-end submission of 3 Annual Reports by collaborating with 5 cross-functional teams, achieving a 20% reduction in preparation time and ensuring 100% regulatory compliance with FDA standards
Authored and compiled 15+ regulatory documents, including IND Clinical study documents, Meeting Requests, Briefing Document, Designation Requests, improving document preparation efficiency by 25%
Conducted Regulatory precedent research for 5 disease areas and labeling in collaboration with Regulatory Intelligence, supported expansion into 3 therapeutic areas and cut labeling review time by 2 weeks
Developed a standardized IND content plan in collaboration with Regulatory Project management, adopted for all future submissions, streamlining workflows and reducing preparation time by 30%
Assisted with 2 FDA meeting preparations by profiling reviewers, and summarizing meeting discussions, providing strategic insights that improved regulatory decision-making and submission planning

Conducted market research, identifying predicate medical devices and defining a pathway for 510(k) Premarket Notification
Coordinated 513(g) Request and Q-Submission, resolving 80% identified regulatory uncertainties
Implemented HIPAA/GDPR-compliant data privacy protocols and risk assessments addressing 100+ safety criteria, and designed a Post-market Surveillance plan that improved post-launch compliance and efficacy monitoring

Compiled ANDA filings by preparing Module 1 and 2 documents, tracking regulatory documentation while ensuring CDSCO compliance, reducing document preparation time by 15%
Monitored manufacturing processes for 5 pharmaceutical products, ensuring GMP compliance and prepared Process Validation Protocols and Deviation Reports, improving audit readiness by 25%
Optimized Module 3 CMC documentation for 2 injectable formulations by collaborating with Quality Control, Quality Assurance, and Manufacturing teams, improving regulatory submission efficiency by 20%

Assisted in the preparation and submission of regulatory filings for Capecitabine tablets and Doxorubicin injection.
Gained insights into critical manufacturing processes, including Liquid and Powder vial filling and Lyophilization, ensuring alignment with regulatory standards.
Cross-collaborated with Quality Control, Quality Assurance, and Manufacturing departments, for regulatory document preparation of drug delivery injectables.