Years Of Experience
Projects Completed
Certifications
My Skill Set
Ensuring adherence to global regulatory frameworks including FDA, EMA, GLP, GMP, ICH-GCP, and audit preparedness.
Coordinating international Phase I–III trials, stakeholder reporting, financial forecasting, and cross-functional collaboration.
Managing clinical risks, maintaining Veeva Vault documentation, and reducing regulatory findings through audit readiness.
Why Choose Me
Drafted CMC documents for IND/NDA submissions.
Audited and formatted submissions for North America launches.
Reduced review cycles by 25% through APR documentation improvements.
DEGREE
Clinical Operations, Global Pharma
Clinical Development
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