Understanding Regulatory Affairs Through an IT Lens

For Barbara Hanly, it’s all about making a difference in patient care and health.

After years of working in high-tech—program management and people management roles at companies such as Adobe, Fujitsu and Juniper Networks—Barbara is changing careers to get closer to improving patient care.

Fortunately, she’s not starting from scratch. As the Informatics Portfolio and Program Manager at Genentech, Barbara is able to harness her amassed technical program-management expertise. But what she was missing was the business-context knowledge for pharma and regulatory.

“Our group provides the technology and systems that are used by global regulatory groups at Genentech/Roche,” Barbara explains. “To better partner with the business, I wanted a baseline understanding of the challenges. Two of my colleagues had attended the UC Berkeley Extension’s Professional Program in Regulatory Affairs and recommended it. The advantage of an in-class program is the ability to connect with professionals—to learn their challenges and experiences—and to learn from the course instructors, who are all pharma professionals. I was not the typical student in any of the courses.”

Not the typical student?

I was the only informatics professional in the room, so I had a very different learning experience, goal and perspective. We were all from the biopharm industry, but from different parts of the organization. The other professionals were from pharma regulatory or other science roles such as clinical safety and drug development and who wanted to be able to change roles within their company.

In the discussion areas, I was able to share my IT perspective in the systems that are used for regulatory authoring, editing, publishing and submission to health authorities.

The interaction in the classes provided real-life examples and real business challenges with the changes from global health authorities that regulatory professionals need to anticipate and respond to.

As you’re not working directly in regulatory affairs, how are you applying lessons learned to your current position?

One of my programs is a partnership with the Product Development business, working on transformation changes—such as manual to digital, AI, RPA—so that we can shorten our time to get medicines to patients sooner.

The learning journey has provided me with valuable business-context knowledge and enabled me to contribute in a deeper way—specifically, when I needed to understand new regulatory requirements, the risks and impacts.

An example is how my classmates and I shared regulatory health–authority differences across the global groups and common challenges keeping up with the regulations.

What does earning this certificate mean to you?

Lifelong learning is not only important to me personally, but is valued at my company. The experience is valuable for those students who do not have a professional or advanced chemistry or biology background. Coming from IT, I did not find it a barrier to learning the science.

Connecting with and learning from professionals in the biopharm industry is valuable, so the learning journey is worth it.