Mark Charest - Episode 7 - Regulatory Voices

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 regulatory careers are rarely linear. Mark shares perspectives from across successful programmes, failed studies, restructures, commercial products, and intense pressure development environments, and discusses what those experiences teach you over time about the industry, leadership, and resilience. We also spend time discussing high stakes FDA meetings, what really happens inside the room during critical regulatory interactions, who is actually in the room. Mark shares examples of situations where major programmes and strategies were on the line, and how communication, judgment, and credibility become just as important as the data itself. Finally, we explore how the role evolves from Manager to Director to VP, and why each level requires a completely different mindset. From execution and technical detail, to leadership, foresight, stakeholder management, and organisational influence, Mark gives a very grounded perspective on what progression in regulatory actually looks like in practice. This is a very insightful conversation for those who are currently early in their career or who are making that move from Manager into Director. Brought to you by Codon Partners, Life Science Staffing

Zak Huang - Episode 6 - Regulatory Voices

In today’s episode of Regulatory Voices [https://www.linkedin.com/company/regulatory-voices/], I speak with Zak Huang [https://www.linkedin.com/in/zak-huang/], SVP Regulatory Affairs at Aditum Bio [https://www.linkedin.com/company/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 gap between science, business, and health authorities. We explore how Regulatory thinking evolves over time, in particular, as professionals move into more senior leadership positions. Zak shares thoughtful perspectives on the importance of influence, collaboration, negotiation, and understanding your audience, skills that often become just as important as technical knowledge itself. We also discuss the role of storytelling within Regulatory Affairs, and why the ability to frame data, communicate risk, and guide organisations through uncertainty is becoming increasingly important in modern drug development. Thank you again Zak Huang for joining. Links to other platforms to follow, full written report to go up tomorrow morning as usual. If you enjoyed what you see today, please comment, like and share. Any questions for Zak or myself, put them in the comments. This show is brought to you by Codon Partners [https://www.linkedin.com/company/codon-partners/], Life Science Staffing.

Ashley Preston - Episode 5 - Regulatory Voices

In today’s episode of Regulatory Voices [https://www.linkedin.com/company/regulatory-voices/], I speak with Ashley Preston [https://www.linkedin.com/in/ashleypreston/], SVP Regulatory and Quality at BlossomHill Therapeutics, Inc. [https://www.linkedin.com/company/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 progression in Regulatory and Quality is not just about knowledge. Many people build strong technical foundations early in their careers, but senior leadership increasingly requires influence, communication, stakeholder management, and the ability to adapt your message depending on the audience in front of you. We also discuss executive presence, how leadership styles evolve over time, and the realities of operating across different teams, cultures, and global regions. Ashley shares practical perspectives on how professionals can develop those softer skills without losing the technical credibility that got them there in the first place. Finally, we touch on the importance of understanding the wider business context around Regulatory and Quality, and why the functions are increasingly expected to contribute strategically rather than operate in isolation. This session is ideal for anyone working in Regulatory or Quality who is looking to better understand the leadership side of the profession and what progression beyond the technical layer actually looks like in practice. Thank you again Ashley Preston for joining.

Sterling Chung - Episode 4 - Regulatory Voices

In today’s episode of Regulatory Voices [https://www.linkedin.com/company/regulatory-voices/], I speak with Sterling Chung [https://www.linkedin.com/in/sterling-chung-619b043/]. Sterling is Chief Regulatory Affairs and Quality Officer at Aurion Biotech [https://www.linkedin.com/company/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 working on a drug where precedent does not quite fit, or where applying past experience blindly can actually hold a programme back. A key theme throughout is judgment. Understanding the difference between knowing the regulations and being able to apply them in context. As Sterling explains, knowledge can be learned, but judgment comes from experience, curiosity, and being comfortable operating in the grey. We also explore the role of regulatory as the integrator across a development programme. How it connects CMC, clinical, and non-clinical, and why many companies underutilise regulatory strategically, often treating it as a function rather than a true partner in decision making. Finally, we go into areas where the frameworks are still catching up, particularly in cell and gene therapy and combination approaches. Where there is no clear playbook, and teams are forced to go back to first principles and make decisions without a defined path. This session is ideal for anyone working in, or looking to move into, regulatory affairs who wants a more realistic view of how the role operates beyond guidance documents. Thank you again Sterling Chung for joining.

Andie Collier - Episode 3 - Regulatory Voices

In todays episode of Regulatory Voices [https://www.linkedin.com/company/regulatory-voices/], I speak with Andie Collier [https://www.linkedin.com/in/andiecollier/]. 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 Andie Collier [https://www.linkedin.com/in/andiecollier/] for joining!