Katja has a Master’s in Pharmacy and has been with Billev Pharma East since September 2008, responsible for business development, regulatory affairs, and pharmacovigilance, appointed as Director of Regulatory Affairs and EU-QPPV. She started her career in VetConsult Pharma working in various areas with veterinary medicines and afterwards joined Sandoz as Regulatory Affairs Manager and later as a Head of the Regulatory Affairs department. Over the years, she has gained a lot of experience in the regulatory affairs of human and veterinary medicinal products and medical devices.
During many years, she was involved in regulatory strategies, managing procedures, and worked with all European Competent Authorities to obtain and maintain the life cycle of the products.
Her main role in Billev Pharma East is currently Associate Director, with a focus on business development and acting as a EU QPPV for human and veterinary medicinal products. She is also the person responsible for the regulatory compliance for medical devices.
She is a member of different Medicines For Europe working groups, TOPRA, and was also a Member of the EMA eSubmission Change Control Board – from initial set up until the implementation of the new EU telematics governance structure.
Katja spends her free time with her family and practices yoga, Ayurveda, hiking, and enjoying nature. She also likes cooking and spending time with her friends.
