Master of Regultary Affairs
Director of Regulatory Affairs
Alenka has more than 20 years’ experiences working in the pharmaceutical industry on various regulatory affairs positions. She is Bachelor of Chemical Process Technology and holds Master Degree in Regulatory Affairs by TOPRA (The Organisation for Professionals in Regulatory Affairs).
For 15 years she has worked as Regulatory Affairs Manager for generic company Lek Pharmaceuticals, a part of Sandoz, Novartis group on various global projects. She was responsible for all regulatory matters relating to the dossiers’ Modules 2 to 5 of the company’s various human generic products in Europe, Canada, USA (United States of America), LATAM (Latin America), and ROW (Rest-of-the World) countries. Mainly she worked on development projects on CMC drug product part of dossier.
In 2015, Alenka joined Medis pharmaceuticals company and she has worked in various regulatory affairs positions taking care of Europe regulatory issues in development of herbal products, generics and medical devices.
Since 2021 Alenka works in Billev Pharma East as Director of Regulatory Affairs.
Alenka likes spending her free time with family and friends in the nature.