WNS Global Services Hiring for Toxicologist with Regulatory Module Writing

WNS Global Services, part of Capgemini, is hiring a Toxicologist with Regulatory Module Writing Experience – Assistant Manager (AM). The position focuses on toxicological risk assessments, pharmaceutical impurity qualification, scientific writing, and preparation of non-clinical modules for regulatory submissions.

Candidates with 3–5 years of experience in toxicology, safety assessment, or regulatory toxicology and a PhD or M.Sc. in Toxicology, Pharmacology, or Life Sciences can review the eligibility criteria for this opportunity. Employees can work remotely.

Job Details

Position: Toxicologist – Regulatory Module Writing

The selected candidate will conduct toxicological risk assessments, evaluate pharmaceutical impurities, prepare scientific safety justifications, and lead the preparation and review of non-clinical modules for regulatory dossiers.

Key Responsibilities

• Conduct toxicological risk assessments for pharmaceutical, consumer health, and combination products in accordance with global regulatory requirements.
• Perform impurity qualification assessments following ICH guidelines, including evaluations of genotoxic, mutagenic, and process-related impurities.
• Review toxicological literature, safety databases, regulatory guidance documents, and published scientific evidence.
• Author toxicology reports, risk assessment documents, expert opinions, and regulatory submission content.
• Lead the preparation and review of non-clinical modules for regulatory dossiers.
• Provide scientific justifications for toxicological endpoints, acceptable daily exposures (ADE/PDE), impurity limits, safety margins, and risk mitigation strategies.
• Prepare toxicological summaries, risk-benefit evaluations, and responses to regulatory agency questions.
• Evaluate non-clinical and published data for impurity qualification, extractables and leachables assessments, and product safety profiles.
• Monitor global toxicology and impurity assessment requirements from ICH, FDA, EMA, WHO, and regional regulatory authorities.

Eligibility and Qualifications

Candidates should meet the following requirements:

• Experience: 3–5 years in toxicology, safety assessment, or regulatory toxicology within the pharmaceutical, consumer health, or life sciences industry.
• Education: PhD or M.Sc. in Toxicology, Pharmacology, or Life Sciences.
• Hands-on experience in impurity qualification and toxicological evaluation of pharmaceutical substances and products.
• Experience authoring and reviewing toxicology modules for CTD/eCTD regulatory submissions.
• Strong knowledge of ICH guidelines, particularly ICH M7, Q3A, and Q3B.
• Experience conducting literature reviews, safety assessments, and preparing scientific justifications for regulatory submissions.

Required Skills

• Toxicological risk assessment and product safety evaluation.
• Pharmaceutical impurity qualification and toxicological evaluation.
• Regulatory module writing for CTD/eCTD submissions.
• Scientific literature review and interpretation of safety data.
• Preparation of toxicology reports, expert opinions, and regulatory documentation.
• Knowledge of global regulatory guidance from ICH, FDA, EMA, and WHO.
• Scientific writing, interpretation, and stakeholder management.
• Assessment of extractables and leachables and safety margins.

Application Details

• Company: WNS Global Services
• Position: Toxicologist with Regulatory Module Writing Experience – AM
• Work Mode: Remote
• Employment Type: Full-time
• Location associated with the posting: DLF World Tech Park, 10th Floor, Block A2 & A3, DLF IT SEZ, Sector 30, NH8, Silokhera, Gurgaon, India.

Employees can work remotely. Candidates should refer to the original WNS job posting for application instructions.