Hanna Kirk
MSc, CMC Regulatory Affairs Manager
Hanna is a process orientated quality expert with broad understanding of pharmaceutical drug development. She holds Master’s degree in Analytical and Pharmaceutical Science and has Lean Six Sigma Green Belt in Project Management. Hanna has worked more than ten years in pharmaceutical industry at varied roles from subject matter expert to managerial roles. She has been regularly trained in GMP and ISO 9001 quality management systems and she has gained experience on regulatory procedures with FDA, EMA and FIMEA. Hanna has been a contributing member of a team achieving successful marketing authorization approval for NDA/MAA while working at GSK. Hanna will strengthen the CMC team to meet the regulatory targets aligned with TILT strategy.
