Dr. Malena Bodden

Regulatory Affairs Assistant

Frankfurt, Hesse, Germany

About

I am working as a Regulatory Affairs Assistant in an Academic Research Organisation dedicated to breast cancer research. I am supporting the regulatory processes associated with the submission of clinical trials according to the Clinical Trials Regulation. • Preparation and review of regulatory documents • Ensuring compliance with regulatory guidelines • Coordination of clinical trial submission (tracking timelines, ensuring deadlines) I obtained a doctoral degree with a focus on the development of improved cancer immunotherapies, gaining in-depth knowledge in immunology/ immuno-oncology.

Experience

  • Regulatory Affairs Assistant at GBG Forschungs GmbH
    Sep 2023 - Present · 2 yrs 11 mos

  • Georg-Speyer-Haus - Institute for Tumor Biology and Experimental Therapy (Frankfurt am Main, Hesse, Germany)
    • Postdoctoral Scientist
      Mar 2023 - Jun 2023 · 4 mos

      Laboratory of Prof. Dr. Winfried Wels Department: Translational Oncology/Immunotherapy • Development of novel treatment approaches for cancer immunotherapy based on genetically modified NK cells

    • Doctoral Student
      Jan 2017 - Mar 2023 · 6 yrs 3 mos

      Laboratory of Prof. Dr. Winfried Wels Department: Translational Oncology/Immunotherapy • Generation and characterization of genetically modified NK cells for the treatment of solid tumors Thesis title: GD2-specific CAR NK cells for adoptive cancer immunotherapy • Supervision of undergraduate students • Proposal writing for genetic laboratory work and animal experiment application • Writing of scientific publications • Member of FIRST (Frankfurt International Research School for Translational Biomedicine)