Responsibilities:
- Develop and maintain a comprehensive understanding of all applicable regulations.
- Monitor changes in applicable regulations and advise management and technical team of necessary changes to ensure continued compliance.
- Conduct regulatory market research and analysis to identify trends, opportunities, and competitive landscape.
- Compile and maintain regulatory documentation databases or systems.
- Develop comprehensive understanding of mammalian toxicology, animal metabolism and endocrinology. Learn Risk assessment, classification and labelling, literature review and dossier preparation. Collaborate with technical teams to develop the regulatory framework and support in preparing toxicological dossier and risk assessment.
- Perform in silico toxicology assessments using QSAR and read-across approaches. Utilize computational tools such as OECD QSAR Toolbox, DEREK Nexus, and VEGA QSAR for hazard prediction. Conduct endpoint predictions.
Develop and justify read-across strategies based on structural similarity and mechanistic data. Evaluate chemical structures for toxicological alerts and structural analogues.
- Conduct systematic searches of scientific databases to identify relevant toxicological studies. Review and evaluate peer-reviewed publications, regulatory reports, and publicly available data.
- Support Regulatory Managers and toxicology experts to coordinate, prepare, or review regulatory submissions for domestic or international projects.
Requirements:
- Master’s degree - M. Pharm (pharmacology).
- 1 to 3 years of experience in regulatory within the agrochemical, chemicals, biotechnology, or pharmaceutical industry
- Strong communication, negotiation, and interpersonal skills
- Ability to work independently and as part of a team in a rapid-paced environment.
- Robust problem-solving and analytical skills
- Knowledge of global regulatory requirements and industr
📌 Regulatory Research and Toxicology (Pune)
🏢 Auxilife scientific services
📍 Pune
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