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CSL Plasma
26d ago

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

Opfikon
Full-timeOn-siteSenior

Description

In this role, you will lead nonclinical safety strategies for drug development, collaborating with cross-functional teams to ensure regulatory compliance and safety. Your expertise will guide the design of safety studies and the preparation of critical submission documents.

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Requirements

  • PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field
  • 5-8 years of experience in pharmaceutical or biotech industry
  • Proven track record in nonclinical safety assessment and regulatory submissions
  • Strong 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

Doctoral / PhD

Work Experience

5 - 8 years

Tasks

  • Lead and manage nonclinical safety strategies for drug development projects
  • Serve as the primary toxicology representative on interdisciplinary project teams
  • Lead the Nonclinical Expert Team (NCET)
  • Provide scientific leadership from early discovery to regulatory submission
  • Design, budget, and monitor nonclinical safety studies in GLP and non-GLP environments
  • Compile toxicological risk assessments for drug development projects
  • Prepare and review regulatory nonclinical submission documents
  • Collaborate with pharmacology, PK, clinical, regulatory, and CMC teams
  • Present integrated safety assessments to senior management
  • Compile risk assessments for impurities, extractables, leachables, and excipients
  • Stay updated on toxicology guidelines and risk assessment methodologies

Languages

EnglishBusiness Fluent

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