Toxicologist, Regulatory Module Writing Experience

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🌐 Armenia, India – Remote

🇦🇲 Armenia – Remote 🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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WNS

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

⚖️ Legal

📦 Logistics

📣 Marketing

Legal • Logistics • Marketing

WNS is a global business process management company that operates across 13 countries with over 66 delivery centers and employs more than 62,000 people. The organization is committed to inclusivity and diversity, fostering a unique culture of co-creation and continuous learning. WNS offers various career opportunities across the Asia Pacific, Europe, Africa, and the Americas, and prides itself on its transparent and merit-based recruitment process. As a leader in its field, WNS focuses on nurturing future leaders and decision-makers while maintaining a strong emphasis on social responsibility through initiatives like the WNS Cares Foundation.

📋 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 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

• 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

• Employees can work remotely