Caroline Shleifer on founding RegASK and her journey in science and regulatory affairs
![© Caroline Shleifer](/var/wrbm_gb_food_pharma/storage/images/_aliases/wrbm_large/publications/pharmaceutical-science/outsourcing-pharma.com/headlines/markets-regulations/caroline-shleifer-leading-ai-driven-regulatory-intelligence/17588626-1-eng-GB/Caroline-Shleifer-Leading-AI-driven-regulatory-intelligence.jpg)
She has a PharmD-PhD in Medical Physics and is a seasoned professional with a deep understanding of healthcare, law, and regulatory affairs. We were delighted to speak to her as one of our Women in Science to find more about her journey to get where she is now and what she learnt along the way.
Could you give us an overview of your work?
At RegASK, my role is multifaceted, diverse and dynamic, often encompassing a wide range of responsibilities essential for the company's growth and success. I lead the company's vision, strategy, and execution ensuring that the team is aligned with the company’s goals and objectives. I also instil a strong company culture and ensure that everyone is motivated and working towards the same goals. Additionally, I represent RegASK to external stakeholders, including investors, partners, customers, and the media. A key part of my responsibilities is to unite our team towards a common goal and foster adaptability to respond to evolving business needs.
When did you realize you were interested in science - as a young child, teen, or older?
I discovered my interest in science at a young age, fuelled by a curiosity for experimentation and a desire to find rational answers to scientific questions. This passion grew through exposure to new technologies and ideas, as well as my parents' independent careers in healthcare. Their influence inspired me to pursue a path aimed at improving healthcare and medication for the greater good. My academic journey at Université Paris Cité, enriched by diverse coursework and passionate professors, deepened my commitment to impactful work in life sciences and pharmacy. This early exposure, coupled with an appetite to meet people and venture into new things, laid the foundation for my ongoing interest in science and entrepreneurship.
Could you describe your personal journey bringing us to where you are now?
My journey has been shaped by pivotal experiences and an unwavering passion for innovation. It all began with managing a Parisian pharmacy, where I gleaned invaluable insights into team management, human interactions, and healthcare.
I moved several times to different countries and was exposed to different cultures. As Director of Regulatory and Scientific Affairs at SPRIM, I spearheaded diverse global projects spanning the United States, China, and the APAC region. This role deepened my grasp of regulatory affairs and introduced me to the transformative potential of artificial intelligence (AI).
Living in San Francisco for a while, I experienced the rise of digital health technologies, which offer solutions capable of reshaping conventional practices in healthcare and beyond. Witnessing the profound impact of these technologies on patient care, operational efficiency, and user experience fuelled my inspiration.
This convergence of technology and healthcare ignited my passion for leveraging tech-driven solutions to drive positive change and innovation across various sectors. I experienced technology's transformative prowess in tackling complex challenges and enhancing experiences. This led me to founding RegASK—an innovative venture harnessing AI to redefine the regulatory landscape for Life Sciences and Consumer Products.
What challenges did you face - as a woman or otherwise - along the way and what is the most valuable lesson you have learned?
Achieving harmony between family and work requires adjustment and a good support system. Managing time for growing the company while also being present for my family and friends involved delicate balancing and prioritizing.
One of the key lessons was learning to trust my decisions for the company. Having confidence in my judgment empowered me to lead effectively and tackle challenges with resilience.
Challenges are par for the course in entrepreneurship. It's about facing them with the right mindset and approach. Maintaining optimism and seeing challenges as opportunities for growth and learning became guiding principles for me. Leadership comes down to how you will handle the highs and the lows -- it's about pressing ahead with determination and resilience while focusing on your goal.
What ignites your passion in your current role?
As Steve Jobs said, "the only way to do great work is to love what you do." I have a profound curiosity and a genuine passion for technology and science, which fuels my drive to create innovative solutions and push boundaries.
Additionally, I find immense fulfilment in collaborating with a diverse and talented team, as well as interacting with clients who share our vision of making a positive impact. Working together on groundbreaking projects that contribute to the greater good is incredibly gratifying.
The thrill of discovery, dynamic interactions, and the fulfilment of overcoming obstacles and achieving collective success on this exhilarating journey are what truly inspire and drive me each day.
What is your current work ethos/style?
My work style leverages curiosity and enables collaboration and proactive problem-solving. I'm passionate about cultivating a team culture where we tackle challenges head-on with positivity and a foster a hunger for innovation. We thrive on openness and teamwork, leveraging everyone's unique strengths and ideas to achieve our goals. I'm dedicated to empowering our team to push boundaries and succeed, embodying a relentless spirit of dedication and perseverance in everything we do.
Could you share some advice for young women starting to develop an interest in science or wanting to pursue a career like yours?
Young women should embrace collaboration and foster a team culture where challenges are met with positivity and openness. They should approach problems with a proactive mindset, always willing to explore new solutions and innovative approaches. It's crucial to maintain confidence in their abilities and be resolute in pursuing their goals. Perseverance through challenges and setbacks is key, staying dedicated to their path and objectives. Cultivating a continuous curiosity for learning and discovery will drive their passion and growth in science. They should also encourage a supportive environment that values everyone's contributions and fosters growth and achievement. Always look for ways to innovate and improve, supporting and empowering their team to succeed in all endeavors.