Medical Secretary, Nykøbing F. Hospital (1980)
Diploma in Business Organisation, Copenhagen Business Academy (1998)
Certified Project Manager, IPMA (2007)
Helle Ørbæk is part of the Regulatory Affairs Operations Team. She has extensive experience in eCTD strategies and compiling (hereunder training of clients), using docuBridge as the eCTD tool, Document management and Regulatory IT solutions Furthermore, extensive experience in Quality System Management (DS/EN ISO 9001).
For more information about Regulatory Affairs Operations Team click here