Burcu Erdur
Global Regulatory Affairs Country Lead & Cmc at Mabxience
Based in Spain
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Seniority
Other
Department
Other
Location
Spain
Industry
Pharmaceutical Manufacturing
Company size
1.3K
Contact information
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b•••••••@mabxience.com
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Background
About Burcu Erdur
Motivated,dedicated,visionary Regulatory Affairs and Market Access Leader Manager with over 18+ years of cross-functional experience in the pharmaceutical and biotechnology sectors. Proven track record in leading regional and global regulatory strategies, CMC authoring, lifecycle management, and health authority interactions across EU, APAC, JAPAN, CIS, and MENA regions. Recognized for delivering successful launches, navigating complex regulatory frameworks, and building high-performing teams. Strong expertise in biosimilars, orphan drugs, and strategic market access, combined with exceptional stakeholder engagement across corporate, governmental, and cross-border functions.Team player with excellent communication and presentation skills; able to develop collaborative relationships with various stakeholders both internal and external to achieve objectives. Result and solution-oriented professional with innovative, proactive, flexible and strong ability on problem solving and reporting
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