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Edyta Niemczyk is a seasoned professional in regulatory affairs and drug product development, currently serving as a Regulatory Affairs Manager at Theradex Oncology since March 2020. Niemczyk's extensive experience includes roles as an Owner providing consulting services at RegPharma, and as a Regulatory Affairs Manager at Dystrogen Gene Therapies, focusing on gene therapy for Huntington's disease. Prior positions include Chief Operations Officer and Regulatory Affairs Director at Dystrogen Therapeutics, and Head of the Unit of Clinical Trials Registration at the Office for Registration of Medicinal Products. With a strong academic background including a PhD in Molecular Biology, and specialized training in clinical trial management, Niemczyk has contributed to a variety of life science projects, developing regulatory strategies and scientific documents for major regulatory bodies.