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Current Experience

  • 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) 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)

Past Experience

  • 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.

  • Regulatory proffesional

    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.

  • Chemist

    June 1996 --- February 1998
    responsible for filling and Packaging of norditropin and f7 including Validation of equipment teamleader and shift work


LinkedIn Assessment :
Pharmaceutical IndustryGCPClinical trialsClinical DevelopmentBusiness PlanningProduct developmentProcess improvementRegulatory affairsDrug DevelopmentPharmacovigilanceBiotechnologyLife SciencesDiabetesFDAValidationMedical DevicesGMP


  • 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
  • P2I in from Power2Influence in 0000

Area / Region

Virum, Denmark


Driving License
  • No

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