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Principal Scientist, Regulatory Toxicology(m/w/x)
Description
You will safeguard patient safety by conducting expert toxicological assessments and managing manufacturing deviations, ensuring every product meets the highest global regulatory standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
Languages
English – Business Fluent
- CSL PlasmaFull-timeOn-siteSeniorOpfikon
- CSL Behring
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Principal Scientist, Regulatory Toxicology(m/w/x)
The AI Job Search Engine
Description
You will safeguard patient safety by conducting expert toxicological assessments and managing manufacturing deviations, ensuring every product meets the highest global regulatory standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
Languages
English – Business Fluent
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
- CSL Plasma
Principal Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorOpfikon - CSL Behring
Principal Scientist, Toxicology(m/w/x)
Full-timeOn-siteSeniorOpfikon - CSL Behring
Senior Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorOpfikon - CSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring AG (CH)
Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Full-timeOn-siteSeniorGlattbrugg