Principal Scientist, Regulatory Toxicology

Location: Zürich

Principal Scientist, Regulatory Toxicology page is loaded## Principal Scientist, Regulatory Toxicologylocations:
EMEA, CH, Kanton Zurich, Opfikon, CSL Vifortime type:
Vollzeitposted on:
Heute ausgeschriebenjob requisition :
R-263627

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:

** Project Toxicology Role:
The Principal Toxicologist will lead and manage nonclinical safety strategies across multiple drug development projects. This role serves as the primary toxicology representative on interdisciplinary project teams, will lead the Nonclinical Expert Team (NCET) and provides scientific leadership from early discovery through regulatory submission and market authorization. The role is responsible for the design, adequate budgeting, and monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment  Regulatory Toxicology Role:
The Principal Toxicologist will compile Toxicological Risk Assessments across multiple drug development projects supporting R&D, CMC and Quality and/or will compile nonclinical submission documents across all projects.
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* Main Responsibilities:

** Serve as the Toxicology representative on cross-functional project teams and act as NCET lead.  Act as Nonclinical Development representative in Research Project teams.  Design, oversee, and interpret nonclinical safety studies (GLP and non-GLP) to support regulatory submissions and drug development.  Develop and implement toxicology strategies aligned with clinical development plans.  Proactively identify and manage safety risks and liabilities early in development across therapeutic modalities  Prepare and review regulatory nonclinical submission documents  Collaborate with internal stakeholders including pharmacology, PK, clinical, regulatory, and CMC teams.  

Present integrated safety assessments to senior management and at project milestone reviews.  Compile toxicological risk assessments for impurities, extractables and leachables, excipients, and other components in line with ICH, EMA, and FDA guidelines  Stay current with evolving toxicology guidelines and risk assessment methodologies.
** Qualifications and Experience Requirements:
** PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field. 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
** Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, .## **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 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  bei CSL.##
** Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!**### Ähnliche Stellen (1) locations:
EMEA, CH, Kanton Zurich, Opfikon, CSL Vifortime type:
Vollzeitposted on:
Vor mehr als 30 Tagen ausgeschrieben
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