Content Writer

• 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 leachables 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

Explore Toxicologist, Regulatory Module Writing Experience at WNS. Review requirements and application details.