Meet Milagros

What’s my story?

I’m a Filipina immigrant and a RegOps professional. Having started out serendipitously as a regulatory assistant, I am fortunate that my regulatory career developed organically in organizations that allowed me to thrive and grow to become a senior director, and connected me with wonderful colleagues, mentors and friends. Nearly 20 years and a myriad of experiences later, consulting seems like a natural progression for me.

What makes me different from other consultants?

I learned regulatory operations from the ground up by doing—from when submissions were paper, to manually creating relative links for eIND submissions and now eCTD. With Veeva, I was a system admin before Vault Submissions was called Vault RIM. When I think of best practices and the way I would approach submissions and RIM systems, those experiences inform my thinking. It’s one thing to know the technical aspects of systems; it’s another to understand regulatory submissions. My work happens where the two intersect, and it’s critical to recognize how both have an impact on each other. I was also a certified teacher, so the way I design and deliver training resonates with people. Whether you’re at the beginning of process definition, in the midst of RIM implementation, or have recently gone live, I am confident that I can add value to your projects.

Why people, process and technology?

I spoke at DIA RSIDM about how combining people, process and technology is essential to successfully manage, run and maintain systems. Just as organizations and drug development programs evolve, so do the processes and systems that support them. Establishing new processes and systems or making changes to them will affect people’s work, so it’s important to be disciplined and realistic about what people can absorb. Just because new system features are available, it doesn’t necessarily mean they need to be used if they do not add meaningful value. Similarly, process changes should make processes more efficient or address new requirements, not create more work. While change is inevitable, it needs to be managed accordingly and with consideration for the impact on people, process and technology. This is the focus of my work.

What motivates my work?

There is no secret; I just love what I do. There are so many innovative companies out there, and I want to do my part to best position organizations to maximize their chance for success. How? By helping build sustainable processes and systems that will support future marketing applications, so that patients can receive the treatments they need.