Toxicologist with Regulatory Module Writing Experience- AM-Remote

Toxicologist with Regulatory Module Writing Experience- AM-Remote

Company Description

WNS, part of Capgemini, is an Agentic AI-powered leader in intelligent operations and transformation, serving more than 700 clients across 10 industries, including Banking and Financial Services, Healthcare, Insurance, Shipping and Logistics, and Travel and Hospitality. We bring together deep domain excellence – WNS’ core differentiator – with AI-powered platforms and analytics to help businesses innovate, scale, adapt and build resilience in a world defined by disruption.Our purpose is clear: to enable lasting business value by designing intelligent, human-led solutions that deliver sustainable outcomes and a differentiated impact. With three global headquarters across four continents, operations in 13 countries, 65 delivery centers and more than 66,000 employees, WNS combines scale, expertise and execution to create meaningful, measurable impact.

Job Description

• 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.

Qualifications

PhD / M.Sc. in Toxicology, Pharmacology, Life Sciences