Principal Scientist, Regulatory Toxicology
Principal Scientist, Regulatory Toxicology
Principal Scientist, Regulatory Toxicology
Principal Scientist, Regulatory Toxicology
CSL
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Opfikon
- Art der Beschäftigung: Vollzeit
- Vor Ort
Principal Scientist, Regulatory Toxicology
Über diesen Job
Job Family: Discovery & Product Development
Job Type: Full Time
Location : Glattbrugg, Zurich, Switzerland
Employer Reference: R-263627
Job Description
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.
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.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .
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CSL
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