Regulatory Voices

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 Staffing, Hosted by Conner Harman, Regulatory Affairs Recruitment Specialist

Regulatory Voices is a science podcast hosted by Unknown Host, with 13 episodes on record and a Required Pod Score of 80. PitchCentric scores this show on Booking Probability, Listen Score, and live audience signals refreshed every 24 hours.

Unknown Host hosts Regulatory Voices, a science show with 13 episodes published.

Our AI reads these to draft pitches. Use them as grounding for a pitch that cites a real guest and a specific topic.

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  Regulatory Voices

  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.

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  Regulatory Voices

  Jonathan Douek - Episode 12 - Regulatory Voices

  Jul 29, 20261h 3m

  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.

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  Regulatory Voices

  Jessica Duffy - Episode 11 - Regulatory Voices

  Jul 21, 202631 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.

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  Regulatory Voices

  Bhargavi Patel - Episode 10 - Regulatory Voices

  Jul 14, 20261h 8m

  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.

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  Regulatory Voices

  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.

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