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Anna Koptina MEng, PhD
Head of Regulatory
Mendus AB
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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. Her experience includes regulatory strategies, expedited programs such as Regenerative Medicine Advance Therapy (RMAT), Fast Track and Orphan Drug designations, multiple interactions with FDA, EMA and European National Regulatory Authorities. Since 20201, Anna works as a Head of Regulatory Affairs at Mendus AB.
Anna also worked within Global Regulatory Affairs at Galderma navigating regulatory requirements for device-based combinational products and bologics. In this role, she was responsible as a regulatory lead for key internal global development projects, as well as for the registration of products in the US, Canada, and 15 markets within the EMEA region.
Anna’s academic journey includes a PhD in Biotechnology, complemented by post-doctoral research at prestigious institutions such as Uppsala University, Bonn University, and Michigan State University.
Anna's expertise lies at the intersection of science and regulatory affairs, making her an asset in advancing innovative therapies.
Anna also worked within Global Regulatory Affairs at Galderma navigating regulatory requirements for device-based combinational products and bologics. In this role, she was responsible as a regulatory lead for key internal global development projects, as well as for the registration of products in the US, Canada, and 15 markets within the EMEA region.
Anna’s academic journey includes a PhD in Biotechnology, complemented by post-doctoral research at prestigious institutions such as Uppsala University, Bonn University, and Michigan State University.
Anna's expertise lies at the intersection of science and regulatory affairs, making her an asset in advancing innovative therapies.