Senior regulatory professional
Since November 2010
Long acting insulin products Tresiba® and Ryzodeg® (Degludec and DegludecPlus) Clinical part of the registration file, phase 3a and 3b clinical trials. Close collaboration with EU, JPN, US and IO. Implementation of the new pharmacovigilence set-up (EMA)
Project management coordinator
June 2007 --- November 2010
Portfolio management, project governance support, project planning structure and resource management, product business planning, Project Manual, Project Risk Management.
September 2006 --- June 2007
Clinical file of the Prandimet submission. International working group with NNI Princeton and NN China.
Group Leader & Specialist, International Product Safety
October 2000 --- September 2006
Potential recalls, complaint and safety handling and coding. Answers and reporting to authorities. Legal cases. Quarterly and surveillence reports. Internal and external audits. Team leader. Lean implementation in the administrative processes.
NNFD National regulatory manager (DK/Iceland)
February 1998 --- October 2000
Danish and Icelandíc marketing authorisations. Local pharmacovigilence and marketing activities. Legal responsibilities in connection with parallel importers. Close collaborations with Iceland.
June 1996 --- February 1998
Responsible for filling and packaging of Norditropin and F7 including validation of equipment Teamleader and shift work
CBS (SIMI) in Medical Marketing Strategy (MMS) from Copenhagen Business School (SIMI) in 2010
Cand Pharm in cand pharm from Danmarks Farmaceutiske Universitet in 1991
High school certificate in Mathematics from Odense Katedral in 1984
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