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 while the organisation focuses on the traditional clinical, CMC and regulatory milestones.This can catch companies much later.Bryce explains how sponsors can progress through Phase 1 and Phase 2 before suddenly facing significantly greater device expectations around Phase 3, pre-NDA or pre-BLA.That can mean design controls, human factors, risk management, quality requirements and device testing all becoming major issues at a point where timelines are already tight.We discuss why that happens, how the device and drug development pathways differ, and what companies should be doing much earlier to avoid remediation work at the end.We also explore what an effective combination product strategy actually looks like, integrated teams, integrated risk management, early FDA interaction and someone capable of bridging the drug and device worlds rather than allowing them to operate in silos.A really practical episode for anyone working around drug delivery systems and combination products.Join us, 8am ET October 6th.Regulatory Voices is brought to you by Codon Partners, Life Science Staffing.

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 understanding regulation is very different from simply knowing or memorising it, and the importance of becoming comfortable operating in the grey areas.The role mentorship played throughout his career, and why finding someone you can genuinely accept criticism from can be so valuable.Whether something has been lost as more people enter Regulatory directly, rather than bringing experience from CMC, manufacturing, clinical or other functions.Why Victor increasingly values regulatory generalists, particularly within smaller biotech companies.And finally, we explore radiopharmaceuticals, an area Victor describes as one of the best career moves he ever made, including the regulatory, manufacturing, safety and logistical challenges that make the space so unique.A wide ranging and easy going conversation covering career development, FDA interactions, judgment, mentorship, leadership and an increasingly important area of drug development.Tuesday 29th September, 8am ET, Live in LinkedIn, available same day on Spotify, YouTube and Apple Podcasts.Brought to you by Codon Partners, Life Science Staffing.

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.

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.

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.

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.

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.

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

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

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.