I have been working in the area of Regulatory CMC now for more than 20 years within biopharmaceuticals, including antibodies at both small biotech and mid-size pharma companies. My experience spans from early development to late phase, including global regulatory submissions and beyond into lifecycle management. I am particularly focused on driving the strategic elements during development for obtaining global regulatory approvals for new biological products as well as complex changes during product lifecycle. Over the years I have enjoyed attending the CASSS forum meetings and I participate actively in CASSS as a member of the organizing committee for the CASSS forum Europe and as CASSS associate director. Other external activities include being one of the course leaders of the module Regulatory Affairs Biopharmaceuticals which is a part of the Masters of Medicines Regulatory Affairs (Atrium/Copenhagen University).