Profilbild von Johanna Lang Project Manager / Consultant Toxicology Preclinics Regulatory Affairs aus Wielenbach

Johanna Lang

verfügbar

Letztes Update: 10.10.2017

Project Manager / Consultant Toxicology Preclinics Regulatory Affairs

Abschluss: nicht angegeben
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (gut) | italienisch (Grundkenntnisse)

Dateianlagen

cv-johanna-lang.pdf

Skills

Project management preclinical (in vivo & in vitro) and up to early clinical studies and development programs 
Toxicological advice, toxicological assessment, immunotoxicological evaluations
Study director GLP and GMP
International sponsors, collaborators and subsidiary
Profound Leadership and Training experience
Precliinical, Toxicological, Regulatory consulting
Medicinal drugs, biologicls, biosimilars, herbals, veterinary drugs, medicinal products, nutritionals, chemicals
Preclinical testing strategies including development of new and tailor-made studies, assays, test systems

Regulatory Affairs Support: compiling dossiers for authorities and professionals (Briefing Book, Investigators Brochure, PSUR, DSUR, RMP, GMP application)
Preparation and scientific review of IND Module 2 (CMC, Nonclinical and Clinical) and 3 documents (CMC), Preparation of BLA, NDA
Preparation of regulatory documents for the European (EMA), U.S. (FDA) and Canadian (Health Canada) Authorities

Projekthistorie

since 2017: Freelancer Project Manager Consultant Toxicology, Preclinics, Regulatory Affairs
2016-2017: Consultant Regulatory Affairs (Bavarian Nordic GmbH, Planegg, Germany)
2010-2016: Training Professional Toxicologist, European Registered Toxicologist (ERT)
since 2015: Project Manager (Aurigon GmbH, Munich, Germany)
2014-2015: Junior Consultant Preclinics (MC Toxicology Consulting GmbH, Vienna, Austria)
2013-2015: Head of Rodent Pharmacology and Toxicology (Aurigon Life Science GmbH, Tutzing, Germany)
2009-2015: Senior Study Director, Project Manager (Aurigon Life Science GmbH, Tutzing, Germany)
2009-2010: Study Director (Aurigon Institue of Drug Research, AIDR Budapest, Hungary)
2008-2009: Study Director, Project Manager (Aurigon Life Science GmbH, Tutzing, Germany)
2006-2008: Associate Study Director (Aurigon Life Science GmbH, Tutzing, Germany)

Reisebereitschaft

Verfügbar in den Ländern Deutschland
In the Greater Munich area
home-office based preferred, but not mandatory
flexible
currently up to 20 h / week
 
Profilbild von Johanna Lang Project Manager / Consultant Toxicology Preclinics Regulatory Affairs aus Wielenbach Project Manager / Consultant Toxicology Preclinics Regulatory Affairs
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