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Veristat Expands Global Regulatory Expertise

Meet Daphne Smyth, Vice President, Global Head of Regulatory Affairs

Veristat is delighted to announce the addition of a seasoned leader to its team. Daphne Smyth has joined Veristat as Vice President and Global Head of Regulatory Affairs. A veteran in the pharma services sector and independent regulatory affairs consultant during her career, Daphne has extensive experience across many aspects of regulatory and drug development, as well as most recently leading and growing global regulatory organizations. 

We asked Daphne to share more about her background and what brought her to Veristat.

👉 Tell us about your background. What expertise do you bring to Veristat?

I have focused on regulatory throughout my entire career— covering many distinct aspects but always within the regulatory arena. I started my career at Bayer AG in Germany in the registration department, compiling dossiers, learning regulatory 101, and then progressing to roles of increasing complexity with regional and global management responsibilities, eventually moving on to small pharma and CROs.

I bring to Veristat extensive experience in regulatory affairs from over 30 years in the pharma industry and CRO roles, with a passion for fostering collaboration and driving growth. While I have worked as an independent consultant, I thrive in dynamic, team-oriented environments. I am really looking forward to getting to know the Veristat team and working cross-functionally. I have a proven track record across the European, North American, and Asia-Pacific regions in building high-performing teams that deliver excellence and ensure high-quality submissions, bringing new treatments to our patients.

👉 What drew you to Veristat?

Overcoming increasingly complex regulatory and operational challenges requires a strong strategic approach and top-notch implementation from people with hands-on experience who can quickly find solutions to hurdles. That is precisely Veristat’s sweet spot. I felt confident the moment I met Veristat’s leaders and our regulatory affairs team that Veristat was the ideal partner to work with and see things through to successful results.

Veristat offers me the ability to continue my passion for regulatory affairs and for accelerating the availability of safe and effective therapies, especially for the vulnerable patient populations we serve. I am thrilled to be here and to work with such incredible clients.

👉 What strategies do you employ to develop and maintain a strong and positive regulatory team across different regions?

Some of the strategies I employ to keep my team strong and positive are prioritizing clear communication, embracing our cultural diversity, fostering growth through continued learning, setting realistic goals, and actively building trust by promoting transparency across all regions. I work hard to ensure everyone feels valued and connected despite our geographical distance.

I have enjoyed working with global teams for many years and am passionate about guiding others in their professional development while championing collaboration within a team environment. I’ve been proud to serve as a mentor throughout my career, and it remains a privilege today.

👉 Where do you see the field of global regulatory affairs heading, and how are you helping clients prepare for these changes?

Building a regulatory affairs function is about more than just ensuring compliance—it’s about fully realizing the potential of our clients’ innovations and helping them find and follow the best development path for their treatments. The future will undoubtedly continue to require a strategic approach to regulatory strategy, one that accelerates development time for sponsors, minimizes their risks, and ensures their innovation reaches patients faster globally.

I anticipate that we will be seeing further advances in integration of real-world evidence (RWE) and AI-driven analytics as well as increased focus on access to clinical trial information for our patients. As a champion of regulatory affairs, I am excited to support our clients in bringing life-changing treatments to patients, knowing that every step forward we take brings hope, healing, and a brighter future for those in need.

Ready to chat with Daphne? Contact her here:
LET'S TALK

 

Read Daphne’s full bio: 

Daphne Smyth
Vice President Global Regulatory Affairs

Daphne Smyth is Vice President Global Regulatory Affairs at Veristat, responsible for oversight of Veristat’s global regulatory functions, serving as trusted advisors to clients through all facets of drug development— from clinical development to market authorization and commercialization.  

Daphne brings to Veristat a wealth of expertise in navigating evolving regulations and advising on the regulatory pathways to therapy approval and commercialization. Her ability to oversee, mentor, and grow teams of scientific experts who engage with Pharma and Biotech clients is proven, championing the critical evaluation of data and execution approaches to bring therapies to market while growing successful business models.



Prior to joining Veristat in 2025, Daphne served in executive leadership roles with increasing responsibility over fifteen years at ICON Clinical Research. She provided regulatory and compliance guidance to internal and external stakeholders and developed and led successful global regulatory affairs teams across Europe, North America and Asia Pacific regions. Daphne’s regulatory career began at Bayer AG in Germany and progressed to encompass all aspects of regulatory affairs across pharma, biotech, and CRO organizations, including acting as an independent advisor. 

Passionate about guiding others in their professional development, Daphne has served as a valued mentor throughout her career. Daphne received her Bachelor of Science degree and certificate in Business Leadership and International Business Management from University College, Dublin and brings expertise from over 35 years in Pharma and CRO businesses. Daphne lives in Dublin, Ireland and loves to travel, read, and learn new languages. She has many more countries and cultures to explore. 

 

 

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