In today’s episode of Regulatory Voices, I speak with Bhargavi Pandit RPh, MS, RAC, a global Regulatory Affairs leader with 15 years of experience across oncology, immunology, and rare diseases.

Bhargavi has worked across large pharma, biotech, and speciality organisations, with experience spanning early and late-stage development, global filings, accelerated pathways, labelling, paediatric strategy, and health authority negotiations.

In this episode, we discuss:

Where AI is genuinely useful in Regulatory Affairs today, and where the conversation moves too far into hype.

Why AI should act as a force multiplier for regulatory professionals rather than a replacement for scientific judgment, experience, and accountability.

What FDA pilots and faster review models mean for sponsors, and why a faster agency does not mean less rigour.

How companies can manage global development when FDA, EMA, PMDA, China, and other health authorities may have different expectations and move at different speeds.

What oncology has taught the industry about regulatory flexibility, accelerated pathways, novel endpoints, and adapting when the treatment landscape changes during development.

We also explore Bhargavi’s progression from execution into strategic leadership, the differences between large pharma and biotech, and why Regulatory needs to be involved early enough to help shape the science rather than simply respond to it.

A really strong conversation on AI, global strategy, therapeutic innovation, and the changing expectations placed on Regulatory Affairs.

The full episode is now live, also posted on Spotify, Apple and YouTube.

Brought to you by Codon Partners, Life Science Staffing.