Ashlesha Singh

As a Regulatory Affairs professional at Eli Lilly for two years, I gained in-depth experience in regulatory writing, CMC documentation, labeling, and responding to Health Authority queries. I worked closely with internal teams and external stakeholders to support submissions across multiple regions, including the FDA and Health Canada. 
My role also involved document editing, quality checks, and maintaining compliance with global regulatory standards. I have hands-on experience with regulatory tools like Veeva Vault, which enhanced document management and submission efficiency. This cross-functional exposure has strengthened my regulatory acumen and positioned me to contribute effectively in a dynamic, compliance-driven environment.

With two years of experience at Eli Lilly, I’ve built a strong foundation in regulatory writing, CMC, labeling, and Health Authority query responses. I’ve collaborated cross-functionally with global teams and gained hands-on expertise with tools like Veeva Vault. My work with FDA, Health Canada, and other regions has deepened my understanding of global regulatory frameworks. This journey has shaped me into a detail-oriented, agile, and compliance-driven professional.

I hold an M.S. (Pharm.) in Medicinal Chemistry from NIPER Ahmedabad, providing a strong base in drug development. A PG Diploma in Regulatory Affairs & Medical Devices further equipped me with practical knowledge of global regulatory frameworks and compliance. Together, they support my effectiveness in regulatory roles.