Anna Koptina Gültekin

Head of Regulatory Affairs

Education: PhD in Biotechnology from All-Russian Research and Technological Institute of Biological Industry (2010) and MsC in Biotechnology from Kazan State Technological University (2005).

Experience: Anna Koptina Gültekin has extensive track record within Regulatory Affairs and development of cell and gene therapies/ATMPs for immuno oncology in the US and EU. Since 2020, Anna works as an independent consultant and has been taking on roles as Head of Regulatory Affairs & Senior Regulatory Advisor for several Biotech companies. Her experience includes regulatory strategies, expedited programs as Regenerative Medicine Advance Therapy (RMAT), Fast Track and Orphan Drug designations, multiple interactions with FDA, EMA and European National Regulatory Authorities.

Anna also worked within Global Regulatory Affairs for Device-based combinational products and Biologics at Galderma, Swiss biotech where she was responsible as a regulatory lead for key internal global development projects as well as for registration of products in the US, Canada and 15 markets within EMEA.

Anna holds PhD in Biotechnology and has been working more than 10 years in science prior to joining Regulatory Affairs. Her academic experience includes Post-Doctoral Research at Uppsala University in Sweden and at Medical Clinic of Bonn University in Germany, Visiting Scholar at Michigan State University in the US as well as Clinical & Industrial Drug development program at Karolinska Institute in Sweden.

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Anna Koptina Gültekin