Johanna Lang verfügbar

Johanna Lang

Project Manager / Consultant Toxicology Preclinics Regulatory Affairs

verfügbar
Profilbild von Johanna Lang Project Manager / Consultant Toxicology Preclinics Regulatory Affairs aus Wielenbach
  • 82407 Wielenbach Freelancer in
  • Abschluss: nicht angegeben
  • Stunden-/Tagessatz: nicht angegeben
  • Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (gut) | italienisch (Grundkenntnisse)
  • Letztes Update: 10.10.2017
SCHLAGWORTE
PROFILBILD
Profilbild von Johanna Lang Project Manager / Consultant Toxicology Preclinics Regulatory Affairs aus Wielenbach
DATEIANLAGEN
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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)
ZEITLICHE UND RÄUMLICHE VERFÜGBARKEIT
In the Greater Munich area
home-office based preferred, but not mandatory
flexible
currently up to 20 h / week
 
KONTAKTANFRAGE VERSENDEN

Ja, ich akzeptiere die AGB

Ja, ich akzeptiere die Datenschutzbestimmungen

Hinweis: der Versand ihrer Kontaktanfrage ist komplett kostenfrei