Executive Summary
Caroline Shleifer is the Founder and Chief Executive Officer (CEO) of RegASK, a pioneering AI-driven RegTech company specializing in regulatory intelligence and compliance solutions. She leads RegASK’s mission to leverage artificial intelligence, particularly generative AI, to transform how enterprises manage regulatory affairs, compliance, and market entry risks globally. Her leadership is characterized by a strong strategic focus on innovation, entrepreneurial initiative, and digital transformation within highly regulated industries such as pharmaceuticals, life sciences, and healthcare.
Current Role and Company Focus
- Title: Founder & CEO at RegASK (since 2018)
- Company: RegASK™ – AI-powered SaaS platform delivering curated regulatory intelligence, enabling businesses in regulated sectors to navigate evolving compliance landscapes efficiently.
- Core Competency: Application of Agentic AI architecture and the world's first vertical Large Language Model (LLM) tailored for regulatory affairs, streamlining regulatory workflows, reducing compliance risk, and accelerating market entry processes.
- Notable Initiatives:
- Led the launch of RegASK’s Agentic AI architecture (July 2025), addressing the growing complexity of regulatory environments and compliance burdens.
- Regularly quoted and featured in leading industry media including Bloomberg, Pharmaceutical Commerce, and Labiotech, underscoring her standing as a thought leader on topics such as tariff impacts on pharma supply chains and regulatory disruption.
- Oversaw RegASK’s expansion efforts empowering African companies to access new markets and establish strategic partnerships, indicating a commitment to global regulatory intelligence accessibility.
Educational Background
- Holds a Doctorat de Pharmacie (PharmD) and PhD in Life Sciences – Pharmacie from Université René Descartes (Paris V), obtained circa 1990-1997.
- Educational credentials underpin her deep expertise in life sciences, regulatory affairs, and pharmaceutical disciplines, informing RegASK’s innovations.
Professional Experience and Expertise
- Prior to founding RegASK, Caroline served as Director of Regulatory and Scientific Affairs - Asia Pacific (APAC) for SPRIM, RegASK’s parent company, where she led initiatives supporting regulatory strategies across APAC and Africa.
- Held a Partner role at Sprim Ventures Pte Ltd, demonstrating experience in venture development, strategic investments, and innovation scouting particularly in life sciences and regulatory technology sectors.
- Extensive background in managing regulatory compliance challenges, innovation scouting in ingredient technologies, and navigating complex regulatory frameworks for life sciences and consumer product industries.
- Skilled in entrepreneurship, artificial intelligence applications within regulatory affairs, strategic business development, and women's leadership.
Industry Recognition and Thought Leadership
- Named as one of the 2025 Pros to Know by Supply & Demand Chain Executive, alongside notable colleagues at RegASK.
- Highly active on LinkedIn and other professional networks, sharing insights on AI’s role in regulatory compliance, digital transformation, and innovation in regulatory intelligence.
- Contributor to key industry discussions on how tariff policies (e.g., Trump’s pharma tariffs) disrupt global pharmaceutical supply chains, emphasizing her expertise in regulatory risk management and trade compliance.
- Frequently participates in podcasts and webinars, providing expert commentary on AI-driven regulatory risk trends and compliance innovation.
Strategic Vision and Market Impact
Caroline Shleifer positions RegASK as a strategic enabler for companies dealing with regulatory complexity, offering scalable AI solutions that enhance compliance intelligence. Under her leadership, RegASK focuses on digitizing traditionally manual regulatory processes, reducing the risk of non-compliance, and transforming regulatory affairs from a burden into a competitive advantage. This vision aligns with evolving industry demands for SaaS-based, AI-enhanced regtech platforms capable of handling global regulations in real time.
Geographic and Contact Information
- Based in New York, NY, US with a global operational footprint, particularly strong ties to APAC and African markets through past roles and RegASK’s expansion efforts.
- Public LinkedIn Profile: [https://www.linkedin.com/in/caroline-shleifer](https://www.linkedin.com/in/caroline-shleifer)
This detailed profile presents Caroline Shleifer as a highly qualified, strategically minded leader at the forefront of AI-powered regulatory technology. Her combination of deep industry knowledge, scientific credentials, and entrepreneurial acumen positions RegASK as an innovative solution provider in regulatory intelligence, with growing recognition in compliance and life sciences circles.
