Regulatory Voices

Recent episodes

1. Beth Weinberg - Episode 13 - Regulatory Voices

   Aug 4, 202656 min

   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 across functions can shape stronger leaders. Why Beth believes professionals should "begin with the end in mind", and how Advertising & Promotion and Labeling provide perspectives that many regulatory professionals never experience. The realities of Big Pharma versus biotech, including when to make the move, why some people leave too early, why others stay too long, and the importance of leaving every role with meaningful achievements you can truly call your own. Why technical excellence alone is no longer enough, and how communication, influence, business acumen and leadership increasingly determine career progression. The difference between getting a seat at the table and earning one, and what Regulatory leaders can do to become trusted strategic partners rather than simply technical experts. There were also some great discussions around coaching versus mentoring, creating opportunities for others, building influence across an organisation, and how AI is already beginning to change the way regulatory professionals work. Hope you all enjoy this one! Brought to you by Codon Partners - Life Science Staffing.

2. Jonathan Douek - Episode 12 - Regulatory Voices

   Jul 29, 20261 hr 3 min

   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. In this episode, we discuss: How Jonathan created his own route into Regulatory Affairs after fellowship rejections, and the role mentorship and relationship-building played throughout his career. What large pharma gave him early on, what changed when he moved into a smaller company, and how he adapted when he unexpectedly found himself operating as an interim regulatory leader. Why experience matters more than titles, and why he is deliberately focused on building the right foundations rather than rushing towards the next position. Contribution of components in modern oncology development, why it becomes especially challenging in rare disease settings, and why smaller companies need to consider it much earlier than the registrational stage. We also discuss FDA interactions, regulatory strategy as a constantly evolving process, and why failures, delays and setbacks are often where some of the most important career lessons are learned. Thank you again Jonathan, it was a pleasure to record this episode. Regulatory Voices is powered by Codon Partners , a US focused Life Science Staffing company.

3. Jessica Duffy - Episode 11 - Regulatory Voices

   Jul 21, 202630 min

   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 Regulatory, including the early learning curve, building confidence and the importance of strong managers and mentors. How transferable Regulatory skills are between different therapeutic areas and development environments. The role AI is beginning to play in Regulatory Affairs, where it can genuinely improve efficiency and where human judgment, accountability and decision-making remain essential. We also discuss what people entering Regulatory today should be doing to prepare themselves, from networking and communication to building confidence with new technologies without becoming overly reliant on them. A really interesting and honest conversation about entering the profession, progressing through the early stages of a Regulatory career and how the function may continue to evolve. Episode 11 of Regulatory Voices will be available on YouTube, Spotify and Apple Podcasts after the episode airs. Brought to you by Codon Partners , Life Science Staffing.

4. Bhargavi Patel - Episode 10 - Regulatory Voices

   Jul 14, 20261 hr 7 min

   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.

5. Robert Califf - Episode 9 - Regulatory Voices

   Jul 14, 202647 min

   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 faster than ever? Dr Califf speaks very openly about the public health mission inside FDA, the importance of career expertise, the pressure facing the agency, and why experienced reviewers carry judgement that cannot simply be replaced by guidance documents, training programmes, or AI. We also discuss the modern information environment, misinformation, the decline in trust, and why public health is increasingly competing in a space where evidence is not always what travels fastest. A huge thank you to Dr Califf for joining me and for sharing such a thoughtful, direct, and important perspective. The full episode is available now. Brought to you by Codon Partners, Life Science Staffing.

6. Nataskia Lampe - Episode 8 - Regulatory Voices

   Jun 30, 202635 min

   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 else wanted, moved through graduate school, Department of Defense clinical trial work, IRB compliance, consulting alongside former FDA reviewers, smaller companies, big pharma, asset strategy, and eventually back into biotech leadership. We also discuss the idea of “cross-pollinating” in Regulatory. Nataskia shares what it is like to move across CMC, clinical, legal, quality and asset strategy while still keeping the regulatory lens at the centre. In smaller companies especially, regulatory professionals often have to go deeper into areas outside their core function, not because it is neatly written into a job description, but because the business needs it. Finally, we explore the difference between health authority interactions at large pharma companies and small biotechs. She also shares a very grounded perspective on how the room changes, how decision making changes, how preparation changes, and why credibility, judgment and knowing when to bring in the right expertise matter so much. One line from Nataskia really stayed with me and we can all take with us: “Everything you have ever wanted is on the other side of fear” Brought to you by Codon Partners , Life Science Staffing

7. Mark Charest - Episode 7 - Regulatory Voices

   May 26, 202637 min

   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

8. Zak Huang - Episode 6 - Regulatory Voices

   May 19, 202648 min

   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 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 , Life Science Staffing.

9. Ashley Preston - Episode 5 - Regulatory Voices

   May 13, 202645 min

   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 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.

10. Sterling Chung - Episode 4 - Regulatory Voices

    May 13, 202651 min

    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 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.

11. Andie Collier - Episode 3 - Regulatory Voices

    May 13, 202650 min

    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 Andie Collier for joining!

12. Nicolas James - Episode 2 - Regulatory Voices

    Apr 21, 202642 min

    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 really means. Not just following guidance, but interpreting it, making decisions in uncertain environments, and learning how to operate in the grey areas that define modern drug development. A key theme throughout is that you can read all the guidance documents you want, but real understanding comes from experience, judgment, and the people around you. We also explore the differences between large and small organisations, what changes during an acquisition, and how to think about building a career in regulatory today. Finally, we take a deeper look at the psychiatric space. Drawing from his early experience and current work, Nic shares a grounded perspective on the unmet need that still exists, the challenges in developing new treatments, and where the field is heading, including the shift towards more personalised, data driven approaches. This session is ideal for anyone working in, or looking to move into, regulatory affairs who wants a practical, honest view of the role. Thank you again Nic for joining! Links to other platforms to follow, full written report to go up tomorrow morning. If you enjoyed what you see today, please comment, like and share! Any questions for Nic or Me, put in the comments. If you would like to be apart of the show in the future please reach out me.

13. Huong Huynh - Episode 1 - Regulatory Voices from Regulatory Voices

    Apr 15, 202645 min

    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 AI is to "Trust but Verify" a common phrase I am hearing more and more. Massive thank you to all who supported so far, if you have any questions for myself or Huong, feel free to comment below or message directly. If you would like to be on the platform, reach out and lets talk about what your passionate about. This interview and community is brought to you by Codon Partners, Life Science Staffing Agency, hosted by Conner Harman, a Pharma & Biotech Regulatory Affairs Specialist Recruiter