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Principal Scientist, Regulatory Toxicology(m/w/x)
Leading nonclinical safety strategies for plasma-derived drug development. 5-8 years pharma/biotech industry experience required. Scientific leadership across full drug development lifecycle.
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
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
Work Experience
- 5 - 8 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
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Principal Scientist, Regulatory Toxicology(m/w/x)
Leading nonclinical safety strategies for plasma-derived drug development. 5-8 years pharma/biotech industry experience required. Scientific leadership across full drug development lifecycle.
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
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
Work Experience
- 5 - 8 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
CSL Plasma
Industry
Pharmaceuticals
Description
Das Unternehmen betreibt eines der weltweit größten Netzwerke von Spendezentren für menschliches Blutplasma und stellt lebensrettende Therapien her.
Not a perfect match?
- CSL Behring
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Principal Scientist, Pharmacokinetics (PK)(m/w/x)
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