Podcast · Tech & Science

Regulatory Voices

by Hosted by Conner Harman - Powered by Codon Partners · English · Tech & Science

Regulatory Voices shares real conversations from across Regulatory Affairs in Pharma & Biotech covering careers, strategy, and the realities of the role. Built for professionals at every stage to learn, connect, and engage with the regulatory community. Powered by Codon Partners, US Life Science Sta

New episodes: Weekly
Typical length: 47 min
Latest: 6 Oct 2026
Language: English

Latest episode

6 Oct 2026 · 39 min

Bryce Whited - Episode 15 - Regulatory Voices

In the next episode of Regulatory Voices , I speak with Bryce Whited, Ph.D. , Founder at WCI MedTech , a regulatory professional with 20 years of experience across FDA, medical devices, combination products and consulting. Bryce began his career as a Lead Scientific Reviewer within FDA’s Center for Devices before moving into industry, where his perspective on regulatory strategy became much broader. A large part of our conversation focuses on the point where Pharma becomes MedTech. When a drug or biologic includes a delivery device, the device component can sometimes become an afterthought…

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Earlier episodes 14 most recent

29 Sep 2026 · 1 hr 14 min
Victor Paulus - Episode 14 - Regulatory Voices
Kicking off series 3, next week on Regulatory Voices , I sit down with Victor Paulus Ph.D, a senior regulatory leader with more than 30 years of experience across vaccines, women’s health, biologics and radiopharmaceuticals. Victor has had a fascinating route into Regulatory Affairs, beginning his career in the laboratory and vaccine manufacturing before making the move into Regulatory and eventually leading functions across multiple organisations. In this episode, we discuss: How moving from manufacturing into Regulatory completely changed the way Victor thought about the FDA. Why…
4 Aug 2026 · 56 min
Beth Weinberg - Episode 13 - Regulatory Voices
On the next episode of Regulatory Voices , I sit down with Beth Weinberg , Chief Regulatory and Safety Officer at Apnimed , who brings more than 30 years of experience across drug development and Regulatory Affairs, including over two decades at Eli Lilly before moving into biotech leadership. This was one of those conversations that moved well beyond regulations themselves and into careers, leadership and what it really takes to become an effective regulatory professional. In this episode, we discuss: Why there is no single "perfect" pathway into Regulatory Affairs, and how experiences…
29 Jul 2026 · 1 hr 3 min
Jonathan Douek - Episode 12 - Regulatory Voices
In this next episode of Regulatory Voices , I sit down with Jonathan Douek, PharmD, MS , Senior Director and Global Head of Regulatory Affairs at Oncolytics Biotech Inc. Jonathan’s career has taken him from an FDA externship and early regulatory roles at Amgen, through a rapid progression at Dynavax, to leading global regulatory strategy within a clinical-stage oncology biotech. This was a really honest conversation about building a regulatory career without a perfect roadmap, growing into leadership before you necessarily feel finished, and the realities of oncology combination development.…
21 Jul 2026 · 31 min
Jessica Duffy - Episode 11 - Regulatory Voices
In Episode 11 of Regulatory Voices , I speak with Jessica Duffy (Weckhorst) , a Regulatory Affairs Manager at Apogee Therapeutics with experience across small molecule oncology and monoclonal antibodies in inflammation and immunology. Jessica’s path into Regulatory Affairs began with a PhD in computational biosciences, before she made the transition from academia into industry. In this episode, we discuss: How Jessica discovered Regulatory Affairs and why the combination of science, business and law made it the right long term career for her. The realities of the first five years in…
14 Jul 2026 · 1 hr 8 min
Bhargavi Patel - Episode 10 - Regulatory Voices
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…
14 Jul 2026 · 47 min
Robert Califf - Episode 9 - Regulatory Voices
In today’s episode of Special Episode of Regulatory Voices, I speak with Dr Robert Califf, former two-time Commissioner of the U.S. Food and Drug Administration. This conversation sits right at the centre of many of the questions being discussed across the regulatory community today. How does FDA function as an institution? What happens when experienced reviewers and leaders leave? How serious is the loss of institutional memory? Can public trust in healthcare and science be rebuilt? And how do regulatory systems adapt when technology, misinformation, and public expectations are all moving…
S2 · E1 · 30 Jun 2026 · 35 min
Nataskia Lampe - Episode 8 - Regulatory Voices
In today’s episode of Regulatory Voices , I speak with Nataskia Lampe , a regulatory affairs leader with more than 20 years of experience across pharma, biotech, global regulatory strategy, Reg CMC, operations and asset strategy. This is a really open conversation about what a non-linear career in Regulatory Affairs can look like, and how each unexpected step can add something valuable over time. What I found really interesting about Nataskia’s journey is that she did not set out on a traditional regulatory path. She started in the lab, stepped into a laboratory compliance role that no one…
S1 · E7 · 26 May 2026 · 37 min
Mark Charest - Episode 7 - Regulatory Voices
In today’s episode of Regulatory Voices, I speak with Mark Charest, a senior regulatory leader with more than 25 years of experience across development stage biotech, commercial organisations. This is a very honest discussion and reflection about what a long term career in Regulatory Affairs actually looks like behind the scenes. What I found unique about my time getting to know Mark is how he sticks it out at every role he has been in, he embeds himself and takes it as far as he can, until factors outside of his control have changed his direction. Throughout the conversation it’s clear that…
S1 · E6 · 19 May 2026 · 48 min
Zak Huang - Episode 6 - Regulatory Voices
In today’s episode of Regulatory Voices , I speak with Zak Huang , SVP Regulatory Affairs at Aditum Bio . Zak brings a really unique perspective on Regulatory Affairs, one shaped not just by technical expertise, but by how communication, influence, leadership, and storytelling all come together throughout drug development. A consistent theme throughout is Zak’s view that Regulatory is an Art. Not because it lacks structure or scientific rigor, but because success in Regulatory is often determined by how effectively you interpret information, align teams, communicate strategy, and bridge the…
13 May 2026 · 46 min
Ashley Preston - Episode 5 - Regulatory Voices
In today’s episode of Regulatory Voices , I speak with Ashley Preston , SVP Regulatory and Quality at BlossomHill Therapeutics, Inc. Ashley has built his career across both Regulatory and Quality leadership, giving him a broad perspective on how technical expertise, communication, and leadership all intersect as careers progress. In this episode, we explore something that does not get discussed enough in our industry, the transition from being technically excellent to becoming an effective leader and strategic partner inside an organisation. A key theme throughout the discussion is that…
13 May 2026 · 52 min
Sterling Chung - Episode 4 - Regulatory Voices
In today’s episode of Regulatory Voices , I speak with Sterling Chung . Sterling is Chief Regulatory Affairs and Quality Officer at Aurion Biotech and brings over 20 years of experience across big pharma and small biotech, spanning CMC, clinical, labelling, and beyond. Having worked across multiple functions and company sizes, he brings a grounded perspective on what regulatory actually is in practice, and why it is far more than just a set of rules to follow. In this episode, we break down why regulatory is not cookie cutter. Not just in theory, but what that actually means when you are…
S1 · E4 · 13 May 2026 · 51 min
Andie Collier - Episode 3 - Regulatory Voices
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…
S1 · E2 · 21 Apr 2026 · 43 min
Nicolas James - Episode 2 - Regulatory Voices
Thank you for joining us for the next episode of Regulatory Voices featuring Nicolas James, PharmD, MBA . Nic began his career as a pharmacist, including time spent working in a psychiatric hospital, before transitioning into regulatory affairs. Since then, he has built experience across big pharma, small biotech, and been is an acquisition environment and kept on too, giving him a well rounded perspective on how regulatory actually operates in practice and how much your career can change in environment in just a 6 year time frame. In this episode, we break down what regulatory strategy…
S1 · E1 · 15 Apr 2026 · 46 min
Huong Huynh - Episode 1 - Regulatory Voices
Happy to be sharing the first entry in Regulatory Voices where I am joined by Huong Huynh, Director of Regulatory Science at Critical Path Institute. In this first episode we talk about her time in the FDA and some of the mentality in Public Service vs Industry, we then dig deeper into what exactly is Regulatory Intelligence. We also take a deeper dive into the importance of Data Sharing, especially in the Rare Disease space utilising Non Profit Data Repositories. Finally we look at RWE and how AI is currently being used for research and providing regulatory insights, a key theme when using…

About Regulatory Voices

Regulatory Voices is a English tech & science podcast from Hosted by Conner Harman - Powered by Codon Partners. Melo plays each episode straight from the publisher's own feed — no ads added, no account needed — and remembers where you stopped, in this browser only.

Publisher: Hosted by Conner Harman - Powered by Codon Partners
Language: English
Category: Tech & Science
New episodes: Weekly
Typical length: 47 min
Latest episode: 6 Oct 2026
Feed: RSS — paste into any podcast app
Apple Podcasts: podcasts.apple.com/podcast/id1886771468
Rights: 2026 Hosted by Conner Harman - Powered by Codon Partners

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