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 / . in Toxicology Pharmacology Life Sciences Remote Work : Yes Employment Type : Full-time
📌 Toxicologist with Regulatory Module Writing Experience- AM-Remote (Gurugram)
🏢 Wns Global Services
📍 Gurugram
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