Fresenius Kabi | São Paulo, Brazil | Regulatory Affairs & Quality Assurance
I lead the Regulatory Affairs & Quality Assurance department at Fresenius Kabi in Brazil. Our team is responsible for marketing authorizations, regulatory documentation, and pharmacovigilance, ensuring compliance with both local and global requirements. We collaborate with internal and external stakeholders to support market access and business continuity.
In my role I am responsible for ensuring that our operations align with both local and global compliance standards. It involves setting the direction for regulatory initiatives, guiding teams through complex submissions, and driving quality excellence across the organization. I strive to anticipate regulatory trends, mitigate risks, and create strategies that support business growth while maintaining patient safety and product integrity.
A real highlight has been driving the registration of biosimilars for the Biopharma business unit in Brazil. Being involved from day one allowed me to shape regulatory strategy and navigate the challenges of entering this innovative segment. It’s been exciting to see our efforts open new opportunities for the company and deliver real value to patients.
“Regulatory affairs is all about paperwork.” A few years ago, I would have agreed. But today, thanks to digitalization, we’ve moved far beyond that. Our team is already leveraging AI in many of our daily activities, making processes faster, smarter, and more strategic than ever before.
“Strategy”. In Regulatory Affairs and Quality, everything we do needs a clear strategy — whether it’s planning submissions, anticipating regulatory changes, or driving quality improvements. It’s the word that keeps us focused on the bigger picture.
“Deliver well to deliver always.” It reflects my belief that delivering quality and integrity in everything I do builds trust and long-term impact.
Navigating complex regulatory requirements can be challenging, but I actually enjoy it. It feels like solving a big puzzle — figuring out how to meet all the requirements while still moving projects forward. It keeps me thinking and makes the job interesting.