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:
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.
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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 Plasma
CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.
Learn more about CSL Plasma here https://www.cslplasma.com/ and CSL, CSL Behring, CSL Seqirus and CSL Vifor here https://www.csl.com/.
Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.
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 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.
Perks and Benefits
Health and Wellness
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- FSA
- HSA
- Mental Health Benefits
Parental Benefits
- Adoption Leave
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
Work Flexibility
Office Life and Perks
- Commuter Benefits Program
Vacation and Time Off
- Paid Vacation
- Paid Holidays
- Personal/Sick Days
- Leave of Absence
- Volunteer Time Off
Financial and Retirement
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Tuition Reimbursement
Diversity and Inclusion