Toxicologist with Regulatory Module Writing Experience- AM-Remote

• 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