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CSL Behring
2d ago

Principal Scientist, Regulatory Toxicology(m/w/x)

Glattbrugg
Full-timeOn-siteSenior

Description

You will safeguard patient safety by conducting expert toxicological assessments and managing manufacturing deviations, ensuring every product meets the highest global regulatory standards.

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Requirements

  • Advanced degree in Toxicology, Pharmacology, Biomedical Sciences or related discipline
  • Board Certification (ERT or DABT) or equivalent plus
  • 5-8 years pharmaceutical or biotech industry experience
  • Track record in nonclinical safety assessment and regulatory submissions
  • Understanding of GLP regulations, ICH guidelines, and global regulatory requirements
  • Excellent communication, leadership, and cross-functional collaboration skills
  • Experience with CSL’s disease therapeutic areas
  • Experience across multiple therapeutic areas and modalities

Education

Master's degree

Work Experience

5 - 8 years

Tasks

  • Prepare and peer-review toxicological risk assessments
  • Apply advanced SAR and read-across methodologies
  • Set health-based exposure limits like PDE and OEL
  • Assess impurities, excipients, and extractables and leachables
  • Evaluate manufacturing and stability deviations rapidly
  • Analyze impacts on patient safety and product efficacy
  • Collaborate with Global Clinical Safety and Pharmacovigilance
  • Review product technical complaints and trend categories
  • Represent toxicology on interdisciplinary global project teams
  • Build a network of internal and external experts
  • Monitor evolving toxicology guidelines and regulatory trends

Tools & Technologies

GLP regulationsICH guidelines

Languages

EnglishBusiness Fluent

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