- Conduct toxicological risk assessments for pharmaceutical, consumer health, and combination products, ensuring compliance with global regulatory requirements.
- Perform impurity qualification assessments in accordance with ICH guidelines, including evaluation of genotoxic, mutagenic, and process-related impurities.
- Review toxicological literature, safety databases, regulatory guidance documents, and published evidence to support product safety assessments and regulatory decision-making.
- Develop and author toxicology reports, risk assessment documents, expert opinions, and regulatory submission content.
- Lead preparation and review of non-clinical modules for regulatory dossiers
- Provide scientific justification for toxicological endpoints, acceptable daily exposures (ADE/PDE), impurity limits, safety margins, and risk mitigation strategies.
- Support regulatory submissions by preparing toxicological summaries, risk-benefit evaluations, and responses to agency questions.
- Evaluate non-clinical and published data to support impurity qualification, extractables and leachable assessments, and product safety profiles.
- Monitor evolving global regulations and guidance documents (ICH, FDA, EMA, WHO, and regional requirements) relevant to toxicology and impurity assessment.
Required Experience
- 3-5 years of experience in toxicology, safety assessment, or regulatory toxicology within the pharmaceutical, consumer health, or life sciences industry.
- Hands-on experience in impurity qualification and toxicological evaluation of pharmaceutical substances and products.
- Proven experience in authoring and reviewing toxicology modules for CTD/eCTD submissions.
- Strong knowledge of ICH guidelines, particularly ICH M7, Q3A, Q3B, and relevant toxicology regulations.
- Experience conducting literature reviews, safety assessments, and preparing scientific justifications for regulatory submissions.
- Excellent scientific writing, interpretation, and stakeholder management skills.
PhD / M.Sc. in Toxicology, Pharmacology, Life Sciences