Janki A patel
Regulatory CMC Associate
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About
Regulatory Affairs Professional with a master's degree in Drug Regulatory Affairs and extensive hands-on experience in analytical method validation and GMP manufacturing support.
Strong
Knowledge of CMC documentation, Module 3 requirements, and analytical data supporting IND, NDA, and NDA submissions.
Experience
Quality Control Executive - Torrent Pharmaceuticals Limited, Oncology Division - Gujrat, India
(2021-11 - 2024-05)
- Executed analytical method validation, verification, and transfer to support CMC documentation.
- Generated analytical data for specifications, stability, and method performance.
- Prepared validation protocols, reports, and CMC-relevant documentation for APIs and finish products.
- Supported Cleaning validation and maintained GMP- compliant laboratory records.
- Executed change control and QMS activity using Track Wise to ensure FDA compliance.
- Maintained audit-ready documentation aligned with FDA and ICH guidelines.
Quality Control Apprenticeship - Torrent Pharmaceuticals Limited, Oncology Division - Gujrat, India
(2020-10 - 2021-10)
- Assisted in analytical method validation, Routine Analysis and documentation under GMP condition.
Quality Control Trainee - Cadila Pharmaceuticals Limited - Gujrat, India
- Supported QC activities such as sample testing, documentation, and reagent preparation
Education
Master of Science - Drug Regulatory Affairs - Long Island University, Brooklyn, NY (2025-01 - 2026-12)
Master of Science - Organic Chemistry - Sardar Patel University (2018-06 - 2020-08)
