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Malene Mørch Location
Copenhagen, DK
Malene Mørch Work
Chefkonsulent @ (December 2025 - Present)
Director of Quality @ Beritec A/S (June 2025 - Present)
Senior Director, Qualified Person @ (April 2016 - February 2025)
Senior Director of Quality Assurance @ (December 2011 - February 2025)
Director QA, R and D @ (December 2011 - March 2016)
Head of Drug Regulatory Affairs and Quality @ (February 2009 - November 2011)
Director Regulatory Affairs @ (May 2008 - January 2009)
Group Director Product Development @ Ferrosan A/S (October 2003 - April 2008)
Corporate regulatory affairs manager @ (January 1999 - January 2003)
Medical Adviser @ (August 1998 - August 1999)
Registration and Information Manager @ Organon Denmark A/S (April 1995 - September 1996)
Medical Adviser @ (November 1990 - April 1995)
Malene Mørch Education
University of Copenhagen (Københavns Universitet)
Master of Science - MS (Pharmacy)
1983-1990
Malene Mørch Skills
21 CFR Part 11
CAPA
Change Control
Clinical Development
Clinical Trials
Drug Development
FDA
GCP
GMP
GxP
ICH-GCP
ISO 13485
Lifesciences
Medical Devices
Pharmaceutical Industry
Pharmaceutics
Quality Assurance
Quality Control
Quality Management
Quality System
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Sop
V&V
Validation
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 21 CFR Part 11, CAPA, Change Control, Clinical Development, Clinical Trials and more. Malene Mørch has 1 emails on RocketReach.
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