Andreja Lešnik

Senior Toxicologist @ Hikma Pharmaceuticals

About

As a Senior Toxicologist, I focus on nonclinical strategy development and implementation for both standard and complex generic drugs. My work centers on developing and executing nonclinical packages and assessing the safety of impurities to support global regulatory submissions.I work with CROs on study design, oversee the studies they run, and interpret the results to make sure the data is reliable and suitable for regulatory use. I also work with teams across regulatory affairs, CMC, and development to keep the nonclinical strategy aligned with overall program needs.I enjoy the problem-solving aspect of toxicology, identifying what matters, and turning that into clear decisions that support development.

Country

Slovenia

City

Maribor Metropolitan Area

Industry

Pharmaceuticals

Skill

Creative Problem Solving, Regulatory Submissions, Medical Writing, Attention to Detail, Analytical Skills, Risk Assessment, Electronic Common Technical Document (eCTD), Extractables and Leachables, Mutagenic Impurities, Communication, Regulatory Documentation, Health Hazard Assessment, Pre-clinical Studies, Drug Development, Toxicology, Good Laboratory Practice (GLP), QSAR