Helena Ardebrant is a seasoned professional with extensive experience in regulatory affairs and quality management, currently serving as the Senior Director of Regulatory Process at AstraZeneca since September 2014. Helena has excelled in cross-functional roles, focusing on submission excellence for new product applications and line extensions, while also driving quality management system governance. Past positions at AstraZeneca include Senior Director of Quality Standards and Systems, Director of Audit and Inspection, and Regulatory Affairs Director, where Helena led global regulatory strategies and maintained strong relationships with regulatory authorities. Helena’s career also includes key roles at Swedish Orphan International AB and SBL Vaccines, along with a foundational education in Chemical Engineering from KTH Royal Institute of Technology.
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