We are AH - Meet Stephanie Batliner
Hi Stephanie, what is your job and what does your job mean?
I just returned from a 12-month assignment at the global headquarters of Animal Health in Monheim, Germany, working for Regulatory Affairs supporting Regions International – EEMEA. This means that I focused on enabling the registration of Global products for countries in Eastern Europe, the Middle East and Africa. From Monheim we work closely, build relationships with our Regulatory counterparts in the countries to register and maintain products manufactured in our production site in Kiel. Now back in the USA as the Director of Technical Development, I am responsible for Technical Transfer, Formulation and Analytics for the North American Development Center. I hope that the perspective I have gained in Monheim will lead to increased collaboration with Headquarters, to become a better development partner.
What did you like about Monheim and your work there?
I truly enjoyed the experience of working with other countries. Before going to Monheim, my work had been focused on the US business. Bayer truly is a global company. It is interesting to see how our cultural differences impact how we interact with each other and with Regulatory Authorities. For example, a common approach in the USA wouldn’t work in China. The way we approach authorities is quite different. The challenge is to find a different approach to accomplish the same goal.
At Bayer, our mission is “Science For A Better Life”—how do you contribute to this?
Gaining registrations for Bayer’s products for the countries means that we are providing access to safe and effective treatments to both companion and farm animals. Healthy pets improve the quality of life, and in livestock we contribute to healthy and safe protein sources. In Regulatory Affairs, we also do a lot of work on the implementation of company policies.
Describe a typical day?
My day is spent with connecting people to information. We work with colleagues from nearly every department within Bayer. Our Bayer colleagues or third party partners in the countries request information on our Global products for initial registration, renewal registrations, requests from their regulatory authorities, and variations. We then connect them to the information needed. Most often, we start by asking our Regulatory colleague called the “Product Responsible Person” who is the caretaker of the product dossier. The dossier tells the story of our product; from early development, effectiveness and safety trials, all the way through manufacturing and how we test the product to be sure it is of good quality. It is a living document, and we continue to improve and study our products throughout their life cycle. We customize dossiers according to the requirements of each country authority If the necessary information is not in the dossier, we connect with other colleagues in Development, Drug Discovery, Product Supply or Marketing, for example. We also contribute to the life cycle management of the product, so as things change in the manufacturing process, testing, specifications or labeling, we work with the countries to make sure our registrations remain compliant.
How did you get to Animal Health?
I've worked in the animal health industry for 22 years, my whole career. I studied Animal Science at the University of Missouri and afterwards I started out in Quality Control chemistry for an animal health pharmaceutical manufacturer. I gained experience in Quality Assurance, Research and Development, and Regulatory Affairs. I joined Bayer three and a half years ago.
Do you have any pets?
Yes. Maggie is a 10 year old black Labrador and Gypsy is about 3 years old, a mix of Pit Bull and everything else. We adopted Maggie 7 years ago, and Gypsy adopted us 2 years ago – she showed up on our farm and just never left. Therefor we decided to take care of her and her health. For most of my life I have also had cats and horses. My favorite horse of all time was Plaudit’s First (PF), a spunky Appaloosa that was my friend and companion for 20 years.
- Type: Exception