# Andie Collier - Episode 3 - Regulatory Voices

Page: https://stenobird.com/podcast/regulatory-voices-7832619/andie-collier-episode-3-regulatory-voices
Text version: https://stenobird.com/podcast/regulatory-voices-7832619/andie-collier-episode-3-regulatory-voices.md
Podcast: [Regulatory Voices](https://stenobird.com/podcast/regulatory-voices-7832619)
Published: 2026-05-13T14:04:24+00:00
Episode link: https://api.riverside.com/hosting-analytics/media/1a9296f4fb3672d1169ea00cbdb31c644843878a169d8a02e912aaef1e03b954/eyJlcGlzb2RlSWQiOiI4YmYzZWMxYi1kZWRmLTRiYjUtYWNiYi05MmZlOWQ2YjY2MTYiLCJwb2RjYXN0SWQiOiIzMDZhYjVlZi0zMmNiLTQ4OGYtYjEwOS02MTFlNzhiNmJlYjEiLCJhY2NvdW50SWQiOiI2OGZjOTRhN2MxNzM5MTIwOWU0NmJmNDQiLCJwYXRoIjoibWVkaWEvY2xpcHMvNmEwNDg1Njg2NTc4YzdiYmE1ZmZjM2NlL25pY2hvbGFzLXJhZG91eHMtc3R1ZGlvLWgxU1hQLWNvbXBvc2VyLTIwMjYtNS0xM19fMTYtNi0zMi5tcDMifQ==.mp3
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JSON: https://stenobird.com/v1/public/podcasts/regulatory-voices-7832619/episodes/andie-collier-episode-3-regulatory-voices
Duration seconds: 3031

## Resource

In todays episode of Regulatory Voices , I speak with Andie Collier . Andie is a pharmacist by background and has spent over 30 years in regulatory affairs, building experience across big pharma, small biotech, and global leadership roles. Having worked across North America, Europe, and beyond, she brings a well rounded perspective on how regulatory actually operates in practice, and how much the environment you are in shapes both your role and your career. In this episode, we break down the reality of big pharma vs biotech. Not just at a high level, but what it actually feels like working in both. From structured environments with deep expertise, to being in a small company and suddenly leading an FDA meeting as an Associate III. That shift alone highlights how quickly responsibility, exposure, and pressure can change depending on where you are. A key theme throughout is that regulatory is not just about following guidance, it is about understanding people, culture, and context. We explore the differences between FDA and European regulators, where guidance may look similar on paper, but how it is interpreted and applied can be completely different. Understanding that is critical to building the right strategy. We also go deeper into how regulatory has evolved. Moving from a more operational function into something that requires strategic thinking at every level. As Andie puts it, regulatory is not tic tac toe, it is chess. Thinking ahead, anticipating questions, and understanding the boundaries of what is possible are what define strong regulatory professionals. This session is ideal for anyone working in, or looking to move into, regulatory affairs who wants a practical, honest view of the role and how to navigate it across different environments. Thank you again And…

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## Transcript

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