Ms. Kajal Bhambhani

With over thirty years of working experience, Kajal has established herself as a leading expert in Regulatory Affairs, Clinical Trials Management & Clinical Lab operations / accreditations.
Currently serving as an independent consultant in Pharma Regulatory Affairs and Clinical Research, she is also a certified Independent Director by the Indian Institute of Corporate Affairs (IICA).

With over a decade of experience at Dr. Reddy’s Laboratories Limited, she has held diverse roles, including leading Regulatory Affairs, overseeing project and program management, managing clinical development activities, and briefly handling the Pharmacovigilance function.

As Head of Regulatory Affairs, she was instrumental in collaborating with cross-functional teams to shape dossier content and provide regulatory guidance throughout asset development. She led the preparation, review, and submission of Marketing Authorization Dossiers in key regions including India, the US, EU, UK, LATAM, and ASEAN countries. Additionally, she played an active role in regulatory agency meetings with authorities such as the USFDA, EMA (Europe), PMDA (Japan), NMPA (China), and DCGI (India), ensuring compliance across all stages of drug development.

Her career showcases a combination of technical expertise, strategic insight, and a steadfast dedication to continuous improvement and operational excellence. She has earned recognition as a distinguished leader in her field, demonstrated by her accomplishments and roles across esteemed organizations, including Dr. Reddy’s Laboratories Ltd, Quintiles Phase 1 Clinical Trials Ltd, Lambda Therapeutic Research, and Bayer Diagnostics India Ltd.