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Principal Scientist, Regulatory Toxicology(m/w/x)
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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Upload your CV and Nejo AI will find matching job offers for you.
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
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
English – Business Fluent
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Principal Scientist, Regulatory Toxicology(m/w/x)
The AI Job Search Engine
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
English – Business Fluent
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.
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