Toxicologist With Regulatory Module Writing Experience- AM- Hybrid

WNS; Gurgaon; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

WNS in India is seeking a PhD/MSc-level Toxicologist to lead risk assessments for pharma and consumer health products. You will review literature, prepare toxicology modules for CTD submissions, and support regulatory dossiers with scientific justifications.

The role requires expertise in ICH guidelines (M7, Q3A/Q3B) and strong report writing, with collaboration across multidisciplinary teams.

Qualifications

• PhD or MSc in Toxicology, Pharmacology, Life Sciences with relevant experience.
• Experience in toxicology risk assessment and regulatory submissions.
• Experience authoring or reviewing CTD/eCTD toxicology modules.

Responsibilities

• Conduct toxicological risk assessments for pharma and consumer health products.
• Perform impurity qualification assessments per ICH guidelines (genotoxic, mutagenic, process-related).
• Review literature, databases and regulatory guidance to support safety decisions.
• Develop and author toxicology reports, risk assessments and regulatory submission content.
• Lead preparation and review of non-clinical modules for regulatory dossiers.
• Provide scientific justification for toxicology endpoints and ADE/PDE calculations.
• Support regulatory submissions with toxicology summaries and responses to questions.
• Evaluate non-clinical data to support impurity qualification and safety profiles.
• Monitor evolving global regulations (ICH, FDA, EMA, WHO).

Skills

Toxicology

Regulatory toxicology

Impurity assessment

CTD/eCTD submissions

ICH guidelines

Literature review

Scientific writing

Stakeholder management

Education

PhD in Toxicology

M.Sc. in Toxicology

Tools

CTD software

Job description

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 leachableassessments, 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