Auxilife Scientific Services Pvt. Ltd.
Job Title: Scientific Officer / Senior Scientific Officer Regulatory Toxicology
Location: Pune, Maharashtra
Reports To: General Manager & Regulatory Head
Position Summary The Scientific Officer / Senior Scientific Officer Regulatory Toxicology will be responsible for supporting regulatory and toxicological evaluations of agrochemicals, biocides, disinfectants and other regulated chemical products. The role involves reviewing and interpreting toxicological and ecotoxicological study reports, conducting scientific literature searches, QSAR assessments, preparing Safety Data Sheets (SDS), supporting hazard classification and labelling, and contributing to regulatory dossier preparation and submissions.
The position will also involve evaluating regulatory data requirements, identifying toxicological data gaps, preparing scientific justifications and coordinating with clients, external laboratories, CROs and internal regulatory teams to support product registrations in India and international markets.
The Senior Scientific Officer will additionally be responsible for independently managing assigned regulatory toxicology projects, reviewing scientific deliverables and providing technical guidance to junior team members.
Key Responsibilities
1. Regulatory Toxicology and Safety Assessment
- Review, interpret and evaluate toxicology and ecotoxicology study reports in accordance with applicable regulatory guidelines and requirements.
- Assess toxicological endpoints, including acute toxicity, irritation, sensitisation, genotoxicity, repeated-dose toxicity, reproductive toxicity, carcinogenicity and other relevant endpoints.
- Review endocrine disruption assessments and supporting scientific information.
- Evaluate toxicological data for regulatory acceptability and identify data gaps in accordance with applicable regulatory frameworks.
- Support human health and environmental risk assessments for chemical products.
- Prepare scientific justifications, weight-of-evidence assessments and toxicological summaries for regulatory submissions.
- Evaluate toxicological information against relevant OECD guidelines, GLP requirements and international regulatory standards.
2. Regulatory Affairs and Dossier Support
- Support regulatory registration and approval processes for agrochemicals, biocides, disinfectants and other regulated chemical products.
- Prepare, review and compile toxicological sections of regulatory dossiers for submission to regulatory authorities in India and international markets.
- Review regulatory guidelines, data requirements and applicable legislation relevant to toxicology and chemical safety.
- Conduct regulatory data gap assessments and identify additional studies or information required for product registration.
- Assist in preparing responses to regulatory authority queries, technical comments and scientific concerns.
- Monitor regulatory developments and amendments affecting toxicological evaluations and chemical safety requirements.
3. Literature Search
- Conduct scientific literature searches and evaluate published toxicological and ecotoxicological information.
- QSAR assessments using relevant tools and validated models
- Prepare literature review reports, scientific summaries and toxicological justifications.
- Maintain databases of toxicological information, regulatory guidelines, scientific publications and relevant study references.
4. Safety Data Sheets (SDS), Classification and Labelling
- Prepare, review and update Safety Data Sheets in accordance with GHS, EU CLP and applicable national and international requirements.
- Evaluate chemical compositions and toxicological information for hazard classification and labelling.
- Support the preparation and review of product labels, hazard statements, precautionary statements and safety information.
- Ensure consistency between SDS, product labels, toxicological data and regulatory requirements.
5. Study Coordination and Project Management
- Coordinate with external laboratories and CROs for conducting toxicological and ecotoxicological studies.
- Review study protocols, study progress and final reports against applicable regulatory requirements.
- Coordinate with clients and internal regulatory teams to obtain technical information and required study documentation.
- Maintain project records,
regulatory databases and study tracking documents.
- Ensure timely completion and quality of assigned regulatory toxicology projects.
6. Technical Review and Team Support
- Support technical discussions and knowledge sharing within the regulatory toxicology team.
- Review scientific documents and ensure accuracy, consistency and compliance with applicable guidelines.
Additional Responsibilities for Senior Scientific Officer
- Independently manage regulatory toxicology assignments and client projects.
- Review and technically validate toxicological evaluations, literature reviews, QSAR assessments, SDS and regulatory documents prepared by junior team members.
- Provide technical guidance and mentoring to Scientific Officers and junior team members.
- Coordinate directly with clients, CROs and external laboratories on technical and regulatory matters.
- Identify regulatory challenges and recommend appropriate scientific and regulatory approaches.
- Ensure timely project delivery and quality of scientific and regulatory outputs.
Qualifications and Experience
- Master's degree or PhD in Toxicology, Toxicological Chemistry, Life Sciences, Biotechnology, Chemistry, Environmental Science or a related discipline.
- Scientific Officer: 03 years of relevant experience. Freshers with relevant postgraduate qualifications may also be considered.
- Senior Scientific Officer: above 3 years of relevant experience in regulatory toxicology, toxicological assessment, chemical safety or regulatory affairs.
- Knowledge of toxicological endpoints, OECD guidelines, GHS classification and relevant regulatory frameworks.
- Familiarity with GLP study reports, regulatory dossier requirements and chemical hazard assessment.
- Experience in SDS preparation, literature searches, QSAR analysis and regulatory documentation will be an advantage.
Skills and Competencies
- Good understanding of regulatory toxicology and chemical safety assessment.
- Strong analytical, scientific interpretation and research skills.
- Good technical writing and documentation abilities.
- Familiarity with toxicological databases, QSAR tools and regulatory guidelines.
- Solid communication and coordination skills.
- Ability to manage multiple projects and meet deadlines.
- Attention to detail and commitment to scientific accuracy and quality.
Version Nov 2026
📌 Scientific Officer / Senior Scientific Officer Toxicology (Pune)
🏢 Auxilife
📍 Pune