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Malene Mørch Location
Copenhagen, DK
Malene Mørch Work
2025 -now Chefkonsulent @
2025 -now Director of Quality @ Beritec A/S
2016 -2025 Senior Director, Qualified Person @
2011 -2025 Senior Director of Quality Assurance @
2011 -2016 Director QA, R and D @
2009 -2011 Head of Drug Regulatory Affairs and Quality @
2008 -2009 Director Regulatory Affairs @
2003 -2008 Group Director Product Development @ Ferrosan A/S
1999 -2003 Corporate regulatory affairs manager @
1998 -1999 Medical Adviser @
1995 -1996 Registration and Information Manager @ Organon Denmark A/S
1990 -1995 Medical Adviser @
Malene Mørch Education
University of Copenhagen (Københavns Universitet)
Master of Science - MS (Pharmacy)
1983-1990
Malene Mørch Skills
Quality System
Regulatory Submissions
GMP
Pharmaceutical Industry
Medical Devices
Validation
FDA
Regulatory Affairs
CAPA
Clinical Development
Clinical Trials
Regulatory Requirements
ISO 13485
Change Control
Sop
Quality Management
GCP
Lifesciences
Pharmaceutics
Quality Assurance
ICH-GCP
Drug Development
GxP
Quality Control
R&D
V&V
21 CFR Part 11
Ich Gcp
Malene Mørch Summary
Malene Mørch, based in Copenhagen, DK, is currently a Chefkonsulent at Region Hovedstadens Apotek. Malene Mørch brings experience from previous roles at Beritec A/S and ALK. Malene Mørch holds a 1983 - 1990 Master of Science - MS in Pharmacy @ University of Copenhagen (Københavns Universitet). With a robust skill set that includes Quality System, Regulatory Submissions, GMP, Pharmaceutical Industry, Medical Devices and more. Malene Mørch has 1 emails on RocketReach.
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