Providing Regulatory Guidance at BPS

Our Regulatory Affairs team at Baxter BioPharma Solutions navigates a diverse product portfolio and evolving challenges to bring new products to market, support contract manufacturing clients and advance our mission.

An interview with Jenifer Avenatti, Associate Director, Regulatory Affairs, Baxter BioPharma Solutions (BPS)

Tell us about your current role.

Jenifer: I support the Regulatory Affairs team out of Bloomington, Indiana for the BioPharma Solutions business. I also manage a team of people that are part of our Pharmaceuticals business, which includes the oncology products manufactured at Baxter’s Halle/Westfalen, Germany, facility.

We partner with pharmaceutical companies on a very diverse portfolio of products here in Bloomington. As a contract manufacturer, we don't own these products – we provide sterile fill/finish production capabilities on behalf of our clients. But I feel proud to support them, and in doing so, support our mission. 

How does our Regulatory Affairs group help advance our mission of saving and sustaining lives?

Jenifer: I see Regulatory as both a spokesperson and liaison between Baxter and the health authorities. Our objective is to stay compliant with changing regulations, and to communicate regulatory expectations when developing a new product or after a product is approved. In turn, we engage with health authorities to inform them of Baxter's intent and our position on key topics during product development to ensure we can get products approved and to the patient in a timely manner. We also stay in close contact with health authorities throughout the lifecycle of a product.

COVID-19 vaccines are among the diverse products manufactured by BPS in Bloomington. How does it feel to play a role getting these projects to market?

Jenifer: I was very happy and proud to play a role in this project, as were a lot of my colleagues. From a professional perspective, it was a once-in-a-lifetime opportunity to work with regulatory authorities to help bring these products to market during a unique event in history, and we worked with incredible speed to make it happen! 

What do you like best about working at Baxter BioPharma Solutions?

Jenifer: As I mentioned, I think the best part about working for BPS is the variety and depth of the portfolio. There are so many different types of products! Every day is a new day, you don’t know what you’re going to get when you come in, which keeps things interesting. You’re always learning something new and solving novel challenges.

I also enjoy interacting with our clients. We get visibility into their cultures, including their operating systems and how they work. For me it's helpful because I'll notice, 'This is a really good practice, why haven't we thought of that?' We can take snippets and best practices that we see through our partners and integrate into how we work day-to-day, and in turn become a better partner.

In addition, being based in Bloomington has been great for me and my family. As a mother of three, it is important to feel comfortable at home, but to also have enough activities in the area to be able to spend time with my kids. Bloomington is the perfect size town, not too big and not too small. It has everything you will ever need. 

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