Amgen

Lucia Cuadros

Regulatory Affairs Authority

Lucía Cuadros, Sr. Manager of Regulatory Affairs at Amgen Colombia, is a pharmaceutical chemist with an MBA in Project Management and currently studying a Master in Artificial Intelligence in Health. She leads with empathy and integrity, translating complex regulations into patient-focused strategies while empowering people and advancing access to life-saving therapies.

In an exclusive interview with CIOReview, Cuadros shared her views on leading with expertise, empathy, and innovation to improve regulatory impact and patient access.

Key Experiences behind the Role

My career in regulatory sciences spans over 16 years across industries, therapeutic areas, and regulatory frameworks. This diverse path gave me a strong technical foundation and a broader view of how regulation can enable access to health.

A pivotal moment came when I moved from dossier development in Latin America to a role which includes regulatory policy. About four years ago, I felt a strong calling to help shape public policy that could accelerate sustainable patient access. Policy became a passion because it connected me with others, expanded my critical thinking, and taught me to embrace complexity.

Another essential part of my journey has been leadership. I take the responsibility of leading people seriously, aware of the personal and professional impact a leader can have. I strive to support my team in their careers and personal growth, seeing them as whole people.

These experiences —technical depth, passion for policy, and commitment to people— converged at Amgen, where I now work on high-impact regulatory policy and lead with purpose, curiosity, and empathy while we manage the lifecycle of a regulatory complex portfolio. I believe meaningful regulatory work requires rigor, empathy, and shared purpose, and I aim to bring all three into every room I enter.

Leading Differently in the Industry

What sets my leadership apart is authenticity. In a complex field like regulatory affairs, authenticity creates trust, and trust is the foundation of every relationship I build.

I lead with transparency and consistency so people feel safe and aligned, even in times of uncertainty. My vision is of a regulatory world that is scientifically sound and human-centered. Science must always be at the core, but empathy and shared purpose matter too.

 Never let technical rigor eclipse your humanity, and never let empathy compromise your standards 

My style may not follow traditional molds, but I have seen how leadership rooted in authenticity, trust, and human connection can be transformative.

Fostering Creativity Within Structure

I lead with a balance of structure, intensity, openness, and emotional intelligence. Regulatory work is complex and structured by nature, but even creativity needs discipline.

With my team, I emphasize clear strategies, visibility in plans, and precision in follow-up. At the same time, I encourage them to think beyond checklists, reimagine pathways, and question established norms. Innovation comes not because it is easy, but because we build trust.

For innovation to thrive, people must feel safe. I invest in that safety by being transparent, sharing my own failures when relevant, and seeing my team as people first. Self-awareness is also key. I take accountability for how I show up because how I lead myself is how I lead others.

Together, we have built a rhythm of care. We check in, recalibrate, and push each other to grow. Through trust, coherence, and discipline, we raise the bar not for perfection but for purpose.

Collaborating to Shape Regulations

Working within the ANDI Regulatory Committee and others trade associations has been both humbling and impactful. Building consensus during a critical period for Colombia’s regulatory agency has been challenging but essential.

These collaborations are vital for shaping frameworks where trust, co-creation, and dialogue are needed. Our work has been anchored on two goals: ensuring regulatory systems keep patients at the center, and elevating regulatory authorities as strategic health institutions worthy of recognition and investment.

When these objectives are clear, the outcome is a more constructive environment where policy can be co-created, good practices shared, and solutions designed for challenges such as resource constraints, outdated frameworks, or the coming impact of AI on regulatory science.

Policy change does not happen in isolation. It happens in networks, through trust, and in spaces where dialogue bridges disagreements.

The Future of Regulatory Leadership

Two trends excite me most for their potential to transform patient access.

The first is the rise of reliance and convergence frameworks across Latin America. More countries are embedding reliance mechanisms into regulations, allowing national authorities to use the scientific assessments of trusted reference agencies. This frees up capacity for market surveillance and inspections while fostering trust between agencies and stakeholders.

The second is the growing role of artificial intelligence. AI can help regulators and industry analyze evaluation data, identify patterns, and predict dossier risks. Imagine systems that scan decades of evaluations to generate insights, flag inconsistencies, or support horizon scanning. These capabilities could make evaluations faster, smarter, and more aligned with patient and public health priorities.

Industry is also moving closer to global dossier strategies enabled by digital platforms. A “single dossier, multiple submissions” model would increase efficiency while raising expectations of regulatory professionals. Future leaders will need stronger critical thinking, adaptability, and coordination across borders.

I see a future where regulatory science is data-informed, globally aligned, and patient-driven, with leaders acting as system architects connecting innovation to access.

Balancing Rigor with Empathy

Never let technical rigor eclipse your humanity, and never let empathy compromise your standards. Both are essential, and both can coexist.

Regulatory work is detailed, structured, and intellectually demanding, but it is also human-centered. Behind every approval is a patient waiting. Behind every requirement is a real-world implication.

So, build technical mastery: understand the science, know the regulations, and be precise. But also stay grounded in service. Remember who you work for. Listen more than you speak.

When you lead, lead with empathy and emotional intelligence. Be transparent, take accountability, and protect your well-being so you can support others.

And never underestimate connection. Regulation may be structured, but collaboration and trust are what move systems forward. Lead with science, but also lead with soul.