Katja Pecjak has an MSc in Pharmacy and has been with Billev Pharma East, Slovenia since September 2008, responsible for regulatory affairs and pharmacovigilance, currently positioned 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 Head of the regulatory affairs department. Over the years, she has gained many experiences in regulatory affairs of human and veterinary medicinal products and medical devices, regulatory strategies, electronic submissions, pharmacovigilance, project management, launch management and leadership, and is working with all European Competent Authorities to obtain and maintain the life cycle of the products. She is involved in various EGA working groups and was a Member of the EMA eSubmission Change Control Board from the initial set up until the implementation of the new EU telematics governance structure.