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Mr. Stian Brekke has worked in regulatory affairs since 2005, as a regulatory affairs manager, regulatory project leader, and QPPV for 11 years in Pharmaq AS, and since April 2019 as a regulatory affairs director at SMERUD, based in Oslo, Norway. Mr. Brekke has led multiple regulatory submissions to various competent authorities, including marketing authorisation applications, orphan drug designation applications, variation applications, clinical trial applications etc. He has ensured regulatory compliance in close collaboration with clinical R&D units, specialized laboratories, consultants, and regulatory authorities as the regulatory representative in drug development projects.