Heidemarie (Heidi) Buchinger
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Heidemarie (Heidi) Buchinger
- Bis heute 5 Jahre und 11 Monate, seit Juli 2019
Head of Project Management
GBA Group Pharma
- 3 Jahre und 5 Monate, Feb. 2016 - Juni 2019
Head of Regulatory Affairs and Clinical Project Manager
Hookipa Biotech AG
- 10 Monate, Apr. 2015 - Jan. 2016
Regulatory Affairs Manager
Hookipa Biotech AG
- 1 Jahr und 3 Monate, Jan. 2014 - März 2015
Senior Consultant
Michor Consulting and Trade Services GmbH
Main activities and responsibilities: Biotech drug registration at EMA including clinical strategy, CTA application and scientific advice Project management of a large regulatory project including timelines and coordination with project partners Support coordination and execution of global product licensing strategies, drug, food supplements, and medical devices Novel food applications CMC drug dossiers
- 8 Monate, Mai 2013 - Dez. 2013
Senior Consultant
Michor Consulting e.U.
- 4 Jahre und 9 Monate, Aug. 2008 - Apr. 2013
Global Regulatory Affairs Manager
Baxter Innovation GmbH
Support coordination and execution of global product licensing strategies, Preparation of EU and US Clinical Trial Applications (CTA, IND), Preparation of regulatory submissions (CTDs, facility licensing documents) to meet US, EU and Intercontinental (ICH) requirements
- 3 Jahre und 1 Monat, Juli 2005 - Juli 2008
Global Regulatory Affairs Specialist
Baxter Innovation GmbH
Support coordination and execution of global product licensing strategies, Preparation of EU and US Clinical Trial Applications (CTA, IND), Preparation of regulatory submissions (CTDs, facility licensing documents) to meet US, EU and Intercontinental (ICH) requirements
- 1 Jahr und 6 Monate, Jan. 2004 - Juni 2005
Compliance Manager
Boehringer-Ingelheim GmbH
Establishment and further development of a Compliance Service Centre, Organisation of internal and external audits as well as inspections from authorities, Follow up audit and inspection findings and track corrective measures
- 2 Jahre und 5 Monate, Sep. 2001 - Jan. 2004
Quality Expert
Baxter AG
Creation of stability protocols for sterile biopharmaceuticals, Preparation of stability reports for US and EU product licensing submissions, Management of CAPA (corrective and preventive actions), Review and evaluation of deviations from production process, Support process improvement projects
Ausbildung von Heidemarie (Heidi) Buchinger
- 1994 - 2000
Biologie
University of Vienna, Austria
University Education in Biology (special topic Zoology)
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen
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