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Ragnhild M. Løberg is currently Head of Quality and Regulatory Affairs in Bayer AS, Norway, after Algeta ASA was acquired by Bayer in 2014. She started in Algeta i 2002, and as Senior VP Quality and Regulatory Affairs, she had a central role in development and documentation of the medicinal product Xofigo, including the regulatory processes resulting in NDA and MAA approval, as well as the FDA approval of Algeta’s manufacturing facility. Løberg has approx. 30 years’ experience from pharmaceutical R&D mainly in start-up biotech companies, in challenging positions at the intersection of the well-defined documentation and quality requirements given by the medicines agencies, and the real life situation with lack of time and resources.