Principal Scientist, Regulatory Toxicology

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Position Description Summary:

The Principal Toxicologist will prepare Toxicological Risk Assessments (TRAs) across diverse projects supporting R&D, CMC, and Quality, ensuring alignment with global regulatory standards and may author nonclinical submission documents. A key responsibility is the rapid evaluation of unexpected manufacturing, release, or stability deviations to support decisions on patient safety, product quality, and business continuity.

This global role requires strong cross‑functional collaboration and engagement with external experts, including participation in worldwide project teams and assessment meetings.

Main Responsibilities:

• Organize, prepare, and peer-review toxicological risk assessments supporting R&D projects and Quality initiatives.

• Apply advanced toxicological principles—including literature evaluation, SAR/read‑across methodologies, and health‑based exposure limit setting (e.g., PDE/ADE, AI, OEL, TE, TTC).

• Compile comprehensive Toxicological Risk Assessments for impurities, extractables and leachables (E&L), excipients, and other product components, aligned with ICH, EMA, and FDA guidelines.

• Conduct rapid assessments of unexpected deviations during manufacture, release, or stability testing of starting materials, intermediates, or final products.

• Evaluate potential impact on patient safety, product efficacy, and regulatory compliance within stringent timelines.

• Collaborate with Global Clinical Safety & Pharmacovigilance when medical interpretation is required.

• Support the review of Product Technical Complaints, based on product trends and complaint categories.

• Serve as the Toxicology representative on interdisciplinary global project teams across therapeutic areas.

• Foster strong collaboration with internal stakeholders and build a global network of external experts in toxicology and risk assessment.

• Stay current with evolving toxicology guidelines, scientific advancements, and regulatory trends.

Qualifications and Experience Requirements:

• Advanced degree (PhD, DVM, PharmD, MSc) in Toxicology, Pharmacology, Biomedical Sciences or a related discipline. Board Certification (ERT or DABT) or equivalent is a plus.

• 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 is highly desirable.

Was wir bieten

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Über CSL Behring

CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring .

CSL soll so vielfältig sein wie die Welt, in der wir leben

Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL.

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