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Dr. David Carruthers is a clinical development leader with over 20 years of drug development experience spanning the pharma, biotech, and CRO sectors, currently serving as vice president, biopharmaceuticals, clinical operations at AstraZeneca. In this role, he leads global clinical operations initiatives to drive research innovation and accelerate drug development programs. Throughout his career—including prior leadership roles at AbbVie, Allergan, and Covance—he has directed cross-functional, international teams across the US, Europe, and Asia to execute strategic, enterprise-level transformations. He holds a PhD and postgraduate qualifications in Neurology from the University of Southampton and Translational Medicine from King’s College London.

Jonas is a global digital leader transforming how pharmaceutical organizations operate across R&D and patient safety through technology, data, and AI. He recently spearheaded one of the pharmaceutical industry’s first large-scale, big bang implementations of Veeva Vault Safety, modernizing global pharmacovigilance overnight and laying the foundation for AI-powered safety operations. Combining strategic vision with execution excellence, he builds high-performing teams and drives change at enterprise scale to accelerate innovation and improve outcomes for patients worldwide.

Marc is responsible for the growth and execution of the Veeva Regulatory product line. Prior to joining Veeva, he served as client partner and RIM consulting lead at Kinapse, now Syneos Health. Additionally, he spent 14 years in Accenture’s Pharmaceutical R&D practice where he led the regulatory advisory, business development, and alliance efforts.

Dawn began her career in pharmacovigilance in 2010 with United BioSource, where she spent 13 years developing extensive expertise across a broad range of drug safety functions. In January 2023, she joined Amylyx Pharmaceuticals, bringing with her a strong foundation in pharmacovigilance gained from both contract research organization (CRO) and pharmaceutical industry perspectives. Her experience includes, but not limited to, supporting audits and regulatory inspections, leading database migration initiatives, and providing effective vendor oversight and management.

Joe has over 15 years of experience in pharmacovigilance, focusing on patient safety from clinical trials to commercial launch. As the head of safety and PV at Amylyx Pharmaceuticals, his team successfully transitioned from a vendor-hosted Argus database to Veeva Vault Safety in 2023. They are currently working on assessing AI efficiencies, Workbench, and Vault connectors.

Sadia Chaudhry-Zutshi has over 13 years of experience in medical writing, with a primary focus on regulatory documentation and global submissions. She plays a key role in cross-functional collaboration, supporting IND, NDA, and MAA submissions across clinical, medical, CMC, and regulatory teams. Her professional interests include optimizing regulatory processes, advancing submission technologies, and enhancing document quality and consistency. She has worked with Veeva RIM for four years, successfully leading the implementation of Submissions and Submissions Archive and currently advancing publishing capabilities.

Christopher is the associate director of global regulatory solutions enablement at BeOne Medicines. With over a decade of expertise in global regulatory operations, he specializes in optimizing eCTD publishing, as well as configuring and enabling Veeva RIM Vaults. Christopher is passionate about bridging the gap between complex health authority requirements and efficient technology to accelerate patient access to life-saving therapies. He recently served as a key member in the historic Accumulus pilot with Chile’s Public Health Institute (ISP). This trailblazing initiative pioneered Chile’s first-ever fully digital, cloud-based review of a novel oncology dossier, establishing a new model for faster global patient access.

Mandy is senior director, regulatory engagement & digital intelligence (REDI) at BeOne Medicines. Her work focuses on regulatory technology, RIM adoption, organizational change management, and helping teams turn digital investments into tangible business value. Mandy has partnered with Veeva and cross-functional stakeholders to enhance user engagement, simplify complex processes, and foster a culture of continuous improvement and innovation. She enjoys bridging the gap between technology and people—and proving that adoption is ultimately more about humans than software.

Michael has more than 20 years of experience in the regulatory affairs space, spanning regulatory publishing, systems, project management, strategy, and writing in addition to clinical trials transparency. He has worked for small, medium, and large biopharmaceutical companies including Baxter, Allergan, Medimmune, Acadia, and most recently Cytokinetics where he oversees regulatory operations, medical writing, and clinical trials transparency. He holds a bachelor’s degree from Susquehanna University and a master’s degree in regulatory science from the University of Southern California.

Nihar is a strategic healthcare leader with over 20 years of experience in the R&D space, focused especially on directing regulatory operations and global product launches across pharmaceutical, vaccine, and medical device sectors. His professional areas of interest center on driving enterprise-wide data transformation, establishing end-to-end dossier management frameworks, and converting strategies into tactical plans and executing. A pioneer in operational excellence, Nihar’s achievements to date include securing critical regulatory approvals ahead of schedule, contributing to successful product launches, and implementing enterprise-wide asset management infrastructure. He currently serves as senior director of regulatory affairs at Emergent BioSolutions, overseeing regulatory operations, intelligence, project and change management.

Michael has over 25 years of experience in healthcare, medical diagnostics and devices, and pharmaceutical industries where he has held senior quality and compliance leadership positions. Michael has led three successful enterprise-level quality system transformations in the last 15 years at major biotechnology companies.

Vanessa is an assistant director of GxP quality systems with a focus in vendor management at Ionis Pharmaceuticals and a leader in GMP quality and compliance. She brings more than 15 years of experience across GxP quality systems, GMP vendor management oversight, and inspection management. She has a strong track record of applying risk-based approaches to vendor qualification, performance oversight, and inspection readiness. Her professional interests include GMP quality systems governance, vendor oversight, and advancing practical, scalable quality processes that strengthen compliance, operational execution, and business impact.

JT is an assistant director in development IT at Ionis Pharmaceuticals and a leader in quality and regulatory business systems. Over the course of his career, he has led complex GxP system deployments and served as system owner for critical platforms across biotech and pharmaceutical organizations, delivering compliant, scalable solutions that support operational excellence. His professional interests include Veeva platforms, pharmaceutical quality and regulatory operations, and the use of AI and automation to strengthen processes, improve information access, and drive meaningful business impact.

Tara Foltz is the manager of clinical trial learning and training at Johnson & Johnson, where she helps advance training strategies and learning solutions to support study teams and operational excellence. Her extensive background as a clinical research professional spans research nursing, institutional review board (IRB) oversight, clinical trial management, and learning development. Tara brings a strong understanding of study conduct, regulatory expectations, and cross-functional collaboration to high-quality clinical trial execution, reflecting a career-long commitment to patient-centered research, compliance, and continuous improvement.

Stephen is a clinical research professional with 10 years of experience spanning quality and clinical functions. In his current role at Kailera Therapeutics, he focuses on implementing and leveraging clinical technology to help the clinical operations team manage trials more efficiently and compliantly. Stephen thrives in start-up environments, where he enjoys wearing multiple hats and gaining hands-on exposure to all facets of clinical research.

Dee is senior director of regulatory operations at Kailera Therapeutics, where she leads global regulatory submission operations and oversees regulatory technology strategy. With 25 years of experience and RAC certification, she has built and scaled regulatory operations functions at Synageva, Cerevel, and Kailera, supporting submissions across the U.S., Europe, Canada, and Australia. Dee has led multiple Veeva RIM implementations, including launches at Cerevel and Kailera, and is passionate about leveraging technology and process innovation to drive regulatory excellence and accelerate patient access to therapies.

Sandi Harrison is the director of eTMF and inspection readiness at Keenova, where she leads the eTMF team responsible for the oversight and governance of the Veeva Vault Clinical platform and procedures. She brings 25 years of pharmaceutical industry experience, specializing entirely within the document management space. Throughout her career, Sandi has driven operational efficiencies, process improvements, and inspection-readiness initiatives across organizations ranging from small biotechs to global enterprises. She focuses on navigating the evolution of the Trial Master File (TMF) to help organizations maximize resource and technology utilization while maintaining strict quality, procedural, and regulatory compliance.

Joe has worked in regulatory operations for more than 30 years. His experience spans planning, authoring, publishing and registration management. He drives the implementation of Veeva RIM within Merck while fostering strong collaboration.

Gisele is a global life sciences executive with more than 25 years of experience leading quality, manufacturing, and digital transformation initiatives across the pharmaceutical industry. She has led large-scale enterprise programs, including global QC and quality systems implementations across multinational manufacturing networks, driving innovation, data integrity, and operational excellence. Her professional interests include advancing digital quality, AI-enabled transformation, and developing future leaders through coaching and mentorship. She is passionate about improving patient outcomes by building connected, data-driven organizations that deliver meaningful and sustainable change.

Jamison brings two decades of experience to the biopharmaceutical industry, with a career spanning data management, on-site monitoring, study management, and organizational leadership. This diverse background provides him with a comprehensive perspective on the clinical trial lifecycle and enables him to effectively bridge operational, quality, and technology functions. In his current role, Jamison collaborates across teams to lead strategic initiatives focused on optimizing clinical systems, streamlining processes, and driving the successful execution of clinical trials.

Kelsey Edwards is a regulatory information management leader with expertise in regulatory operations, digital transformation, and Veeva RIM. As Director of Regulatory Information Management at Takeda, she leads initiatives that improve data quality, streamline processes, and support global regulatory operations. Her interests include regulatory data strategy, automation, and user enablement. Throughout her career, she has successfully led complex system implementations and global initiatives that enhance regulatory efficiency and compliance.

Ryan Hernandez is a seasoned regulatory operations leader with more than 20 years of
experience in the pharmaceutical industry. At Teva, he is responsible for advancing global regulatory operations strategy, capabilities, and execution across the organization. Throughout his career, Ryan has worked within small, mid-sized, and large pharmaceutical companies, overseeing the
compilation and submission of hundreds of regulatory applications worldwide. He is
passionate about developing regulatory operations professionals and designing efficient,
scalable processes that enable organizations to successfully navigate an evolving global
regulatory landscape.

Brook brings 10 years of experience leading GxP training initiatives including implementing a learning management system and learning experience platform. She is passionate about guiding learning ecosystem evolution to balance compliance, inspection readiness and learner experience.

Ilona brings 20 years of regulatory operations experience spanning large pharma and early-stage biotech, where she has led teams, transformed organizations, and built outsourcing models. She has been involved in more than 30 Veeva RIM implementations, helping companies adopt and scale their systems to work more efficiently. Known for her strategic, problem-solving mindset and her passion for developing people, she is a vision-driven leader who pairs long-term thinking with practical execution. She co-founded Votum Consulting to change the way traditional RegOps vendors work — with the goal of making the space genuinely transformational, particularly as AI reshapes what’s possible.

Anthony provides strategic and operational support to life sciences companies implementing and managing regulatory systems, processes, and submissions. He has over 15 years of experience in the field, working with global regulatory teams and cross-functional teams.

Previously, Anthony held roles at Genentech and Myovant Sciences, where he contributed to the development and execution of regulatory information management (RIM) systems, eCTD publishing and submissions, and SOP and process creation. He managed a team of regulatory operations professionals and was a business owner of the Veeva RIM platform. Anthony is passionate about applying innovative and efficient solutions to complex regulatory challenges and ensuring compliance and quality standards.

Crystal leads Veeva’s government strategy initiatives to modernize data submission standards and platforms. She engages with regulators and customers to shape the future of the submissions ecosystem. As an expert in FDA electronic submissions and health data standards, Crystal contributes to Veeva’s product direction and works with the public policy team to position Veeva as a voice in the industry.

Brad leads product management for Veeva’s Agentic Authoring solution, Falcon Writer. He was a founding member of the Veeva Safety team, then went on to lead product for Submissions, Submissions Archive, and Publishing. He is a co-inventor on a U.S. patent for AI-based document interpretation.

Stephen leads product management for Veeva QualityDocs, Station Manager, and Training products within the Veeva Quality Cloud. Alongside his team of product managers, he drives the product roadmap and execution of high-impact features designed to solve complex industry compliance and operational challenges. Stephen brings 15 years of healthcare technology expertise to his role developing electronic health record (EHR) systems prior to joining Veeva about five years ago.

Ryan is a 15 year Veeva veteran, having spent the first 11 years on the professional services team and later bringing his technical knowledge and customer experience with him to the sales organization. Ryan completed well over 100 implementations across all R&D and Quality Cloud applications both for Pharma and MedTech customers.

Erin has worked as a product manager in highly regulated spaces, including government tech, K12 education, and life sciences, for the past 10 years. Her product mantra is “Can the product be simpler? Then make it simpler.”

Paola leads product strategy for QualityDocs and Station Manager, leveraging over 25 years of diverse Quality and IT experience. Her deep expertise covers enterprise document management, training, QMS, lab, and pharmacovigilance systems. Paola’s unique career journey through industry, consulting, and software provides a comprehensive understanding of the challenges and opportunities in this space. She is passionate about empowering the industry to achieve greater quality compliance and efficiency through evolving document management systems with refined best practices and innovation.

Kelly brings two decades of experience to her role where she is responsible for Registrations and structured data reporting like XEVMPD, IDMP and UPD.

Joby leads the product management team for Veeva LIMS. Joby has over ten years of experience designing and delivering enterprise quality and training solutions for the life sciences market.

Nader drives market growth and product direction for Veeva RIM across North America. He has extensive experience leading R&D implementations and business process changes for global biopharmas. Today, he aligns sales operations with product development to help life science organizations optimize their regulatory workflows.

Ruben Gottardi is a senior solution consultant at Veeva Systems with years of experience architecting and implementing mission-critical enterprise cloud solutions for global life sciences organizations. He specializes in digital transformation and validation management, focusing on translating complex GxP and FDA regulatory requirements into scalable platform strategies that maximize quality and compliance.

Jason is a product manager passionate about helping customers meet their educational goals through technology. He focuses on helping customers while defining and executing the product roadmap for Veeva Training. Prior to coming to Veeva, he worked for 18 years in the education industry as a developer, administrator, and product manager of learning management systems.

Jim has spent his career working on document management solutions for the life sciences industry with the last 14 years focused on eTMF applications. Jim is driven by finding ways to make processes more efficient and to improve user experiences to ultimately make managing TMF documentation easier and to increase the quality of the TMF. Additionally, Jim is interested in how new technologies and insights into data can be leveraged to innovate and drive the industry forward.

Crystal supports Veeva’s largest customers in North America. She has 20 years’ experience with biopharmas and CROs. She is passionate about building processes that keep people at the heart of digital transformation, ensuring technology is an indispensable, fully utilized asset.

Cindy defines the strategic roadmap for assistive agents and drives the delivery of Vault AI features for RIM. Drawing from her implementation and RIM product expertise, Cindy partners with biopharmas to transform their regulatory operations through practical, user-centric AI solutions.

Alison’s 20-year career includes regulatory submissions leadership, consulting, and process optimization. She’s spent six years on Veeva’s RIM team, now leading strategy for the Veeva Labeling application.

Rich leads the product management team responsible for Veeva RIM. Throughout his career, he has been instrumental in developing software solutions that help life sciences organizations accelerate time-to-market while ensuring compliance.

Jason has the great opportunity to do many different things at Veeva. For the last four years, he has led the Clinical Operationss strategy group and our 400+ person Clinical Operationss business within Veeva. Over that period, the team doubled the Clinical Operations revenue and launched three new products.

Kayla is a senior product manager at Veeva, focused on supporting CTMS. Kayla has worked in regulated industries for 10+ years, supporting medical devices and pharmaceutical development.

Angela focuses on features and capabilities that span Veeva RIM, such as active dossier, health authority interactions, and email to RIM. Prior to this, she managed the RIM-Clinical Operations connection and the RIM-PromoMats connection.

Graham O’Keeffe is a leader in GxP compliance and digital learning for the life sciences industry. Graham has been a vocal advocate for moving beyond “check-the-box” compliance. As the General Manager of Veeva LearnGxP, Graham leads the strategic direction for one of the industry’s most comprehensive libraries of accredited GxP training content.

Pratyusha leads strategy for Veeva Falcon and Agentic Authoring. She is accountable for long-term product direction, market growth, and long-term customer success with Veeva’s agentic labor offerings for Regulatory. She has more than 20 years’ experience in product strategy, enterprise customer engagements, and engineering in the life sciences and healthcare industries.

Kristie brings over 10 years of diverse life sciences experience, spanning hands-on laboratory research, quality engineering, and enterprise solution consulting. In her role at Veeva, she specializes in aligning complex platform capabilities with the rigorous compliance and operational standards of global pharmaceutical enterprises. Kristie is at the forefront of laboratory innovation, leading cross-functional efforts to build out advanced laboratory procedures and integrate configurable AI agent capabilities.

Chris Pontisso is the director of product management for Veeva Validation Management. Chris has worked in the Enterprise SaaS software space for nearly two decades, focusing on validation over the last five years.

With over 15 years in life sciences, Nina has been a catalyst for change in digital validation for the past eight years. As a senior strategy lead at Veeva, she is a leading advocate for data-centric methodologies and risk-based approaches, championing digital transformation by driving standardization and unification to modernize validation practices.

Lena has more than 25 years’ experience working with life science customers leading software and business process initiatives. She holds an MD in Pediatrics from the Medical School of Belarusian State University. She is passionate about helping the life sciences industry advance through technological innovation to improve patient outcomes.

Caríosa Switzer defines the product roadmap for Veeva Registrations. Her background is rooted in pharmaceutical regulatory affairs and data management. Prior to product management, she managed R&D Services teams focusing on RIM implementations.

John specializes in connecting Veeva RIM to other Veeva applications including Quality, Safety, Medical, and PromoMats. His current focus areas are enhanced change management between QMS and Regulatory, ad promo submissions between RIM and PromoMats, the new RIM to Medical Connection, and connecting product data across the Veeva ecosystem. John has 25 years’ experience in IT implementations, systems integration, and development.

Nick brings over 20 years of experience to his role as Product Manager for Veeva Labeling. Prior to Labeling, Nick has led the Registrations product management team and owned MedTech features within RIM.

Joseph drives Veeva’s North America enterprise regulatory strategy. He specializes in aligning customer vision with product roadmaps and navigating the unique, regulatory challenges faced by mid-to-large organizations. Throughout his career, Joseph has successfully bridged sales, product management, services, and consulting to deliver high-value solutions to biopharmas.

Jordan has deep expertise across all areas of Veeva RIM. He works within the Veeva Falcon team to bring agentic workflows to Regulatory customers.