Senior Scientist, Regulatory Toxicology

CSL; Emea; On-site; IDR 1.334.890.000 - 2.002.337.000; Full time

Job summary

A leading biotechnology company in Sulawesi Tengah, Indonesia, is seeking a Senior Toxicologist to monitor non-clinical safety studies. The role involves designing safety studies, collaborating with teams, and supporting regulatory submissions. Ideal candidates will have a PhD in Toxicology or Pharmacology, experience in the pharmaceutical industry, and a strong understanding of GLP regulations and risk assessment methodologies. Benefits include a focus on employee well-being.

Qualifications

• 3-5 years of experience in pharmaceutical or biotech industry.
• Board Certification (ERT or DABT) is a plus.
• Proven track record in nonclinical safety assessment.

Responsibilities

• Design and oversee nonclinical safety studies for regulatory submissions.
• Collaborate with internal teams to support drug development.
• Prepare and review regulatory nonclinical submission documents.

Skills

Nonclinical safety assessment

Regulatory submissions

Communication skills

Cross-functional collaboration

Education

PhD or equivalent in Toxicology or Pharmacology

Job description

Description

Description

Summary

Project Toxicology Role : The Senior Toxicologist is responsible for monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment.

Regulatory Toxicology Role : The Senior Toxicologist will support Toxicological Risk Assessments across multiple drug development projects supporting R&D, CMC and Quality and / or will support nonclinical submission documents across all projects.

Main Responsibilities

• Design, oversee, and interpretnonclinical safety studies(GLP and non-GLP) to support regulatory submissions and drug development.
• Proactively identify safety risksand 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.
• Supporttoxicological risk assessmentsfor impurities, extractables and leachables, excipients, and other components in line with ICH, EMA, and FDA guidelines
• Stay current with evolvingtoxicology 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.
• 3-5 years of experience in pharmaceutical or biotech industry.
• Proven track record innonclinical safety assessmentand regulatory submissions.
• Strong understanding ofGLP regulations, ICH guidelines, and global regulatory requirements.
• Excellent communication, and cross-functional collaboration skills.

Experience with CSL’s disease therapeutic areas

Experience across multiple therapeutic areas and modalities is highly desirable.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.