Experienced regulatory affairs professional with a proven track record in managing and delivering high-quality regulatory submissions, including CMC documentation in eCTD format, for global markets such as the US, Europe, Canada, and Greater China. Demonstrates expertise in regulatory governance, health regulatory compliance, and lifecycle management through roles at leading organizations like Novartis and Parexel. Proficient in tools such as DRAGON, CARA, Veeva Vault, Verity, and Agile project management systems. Career focus includes driving excellence in regulatory operations to support product registrations and lifecycle maintenance on a global scale.
TRAINING EXPERIENCE
SEMINARS ATTENDED