I am a regulatory affairs professional with 3 years of experience contributing to drug development and ensuring regulatory compliance across the product lifecycle. My expertise includes preparing and submitting regulatory documents such as INDs, IMPDs, CTAs, NDSs, S(NDS)s, NDAs, and MAAs, with proficiency in CMC documentation, eCTD submissions, and regulatory timeline management. I have supported successful approvals and compliance with Health Canada, FDA, and EMA standards.

I specialize in regulatory strategy, regulatory operations, labeling, and change control assessments, as well…