Marja Hjelmstedt Held is a seasoned professional in regulatory affairs with substantial experience across several prestigious pharmaceutical companies. Currently serving as Senior Regulatory Affairs Manager at Scandinavian Biopharma since September 2022, Marja has previously held similar senior roles at Xbrane Biopharma AB and Sobi - Swedish Orphan Biovitrum AB, including positions as Global Regulatory Affairs Director and Senior Global Regulatory Affairs Manager. Marja’s expertise encompasses the development of regulatory strategies, planning, and executing applications with a primary focus on CMC-related submissions. Prior to these roles, Marja worked at Roche and Meda AB, managing quality assurance and regulatory activities, and began a career in project management at Läkemedelsakademin while also serving as a pharmacist at Apoteket AB. Educational qualifications include a Master of Science in Pharmacy and a postgraduate course in Clinical Drug Development from Uppsala University.
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