Toxicologist, Regulatory Module Writing Experience

WNS

. Conduct toxicological risk assessments for pharmaceutical, consumer health, and combination products, ensuring compliance with global regulatory requirements .

Posted 10/21/2026full-timeRemote • Armenia, IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in toxicological risk assessments and impurity qualification within the pharmaceutical and consumer health sectors, ensuring compliance with global regulatory standards. Proficient in authoring regulatory submissions and conducting thorough literature reviews to support product safety evaluations.

Highest-signal resume keywords

Toxicological Risk AssessmentImpurity QualificationICH Guidelines KnowledgeRegulatory Submission AuthoringScientific Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ToxicologySafety AssessmentRegulatory ToxicologyImpurity EvaluationLiterature ReviewRisk AssessmentData EvaluationToxicology Report DevelopmentRegulatory Dossier PreparationSafety Margin Analysis

Soft Skills

Stakeholder ManagementScientific Interpretation

Certifications & Qualifications

PhD in ToxicologyM.Sc. in Toxicology

Industry Keywords

PharmaceuticalConsumer HealthLife SciencesICHFDAEMAWHOCTDECTDGenotoxic Impurities

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Employees can work remotely