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Christine Hirt Location
Munich, BY, DE
Christine Hirt Work
Management Consultant and Regulatory Consulting Lead @ (June 2024 - Present)
Management Consultant @ (November 2019 - June 2024)
Member of TC215 SC2 (former WG6) at ISO @ (October 2014 - Present)
Director Regulatory Competence Center @ (April 2017 - August 2019)
Managing Consultant @ (October 2012 - March 2017)
Head of Regulatory Affairs @ (October 2004 - September 2012)
Specialist and Project Management Regulatory Affairs and Clinical Research @ (October 2001 - September 2004)
Assistant of General Manager of Sanofi-Synthelabo and H. of BU “Medicine and Industry;Project Coordination @ (March 1998 - March 2001)
Christine Hirt Skills
BPMN
Business Process
CMC
Change Management
Clinical Research
Consulting
Electronic Common Technical Document
FDA
Health Informatics
ICH Guidelines
IDMP
ISO
Life Sciences
Market Access
Pharmaceutical Industry
Project Management
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Standards Development
Strategic Planning
Validation
eCTD
Sales
Marketing
Christine Hirt Summary
Christine Hirt, based in Munich, BY, DE, is currently a Management Consultant and Regulatory Consulting Lead at MAIN5. Christine Hirt brings experience from previous roles at MAIN5, ISO - International Organization for Standardization and EXTEDO. With a robust skill set that includes BPMN, Business Process, CMC, Change Management, Clinical Research and more. Christine Hirt has 2 emails on RocketReach.
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