Assistant Manager Regulatory and Toxicology
5 days ago
1. Regulatory Affairs: -
o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products.
o Liaise with client and regulatory authorities for approvals, clarifications, and queries.
o Maintain up-to-date knowledge of regulatory requirements in India and international markets. o Support risk assessment and labeling compliance for products.
2. Toxicology & Safety Evaluation:
o Review and interpret toxicology, Endocrine disruptors and ecotoxicology study reports.
o Coordinate with external labs/CROs for conducting toxicological and ecotoxicology studies.
o Maintain regulatory and toxicology databases, including study and regulatory guidelines
o Conducting literature search and QSAR analysis
3. Team Management / Leadership Responsibilities:
o Mentor team for ensuring timely and accurate preparation of MSDS (Material Safety Data Sheets), literature review and QSAR analysis
o Oversee the correct classification and labelling according to GHS, local regulations, and international standards.
o Guide the team in managing regulatory registration processes of agrochemical, disinfectants, biocide and food contact material products.
o Track regulatory changes and ensure the team is updated with the latest global guidelines relevant to chemical classification, labelling, and safety reporting.
o Provide feedback and develop skill enhancement plans for team members in regulatory and toxicology functions.
Qualifications & Experience: -
PhD or Masters degree in Toxicology or related field.
1 to 4 years of experience in regulatory affairs or toxicology within the agrochemical /pharmaceutical industry or other related area
Knowledge of Regulatory framework for agrochemical, disinfectants, biocide and food contact material products.
Experience in compiling regulatory dossiers and toxicology reports. - Familiarity with GLP and regulatory compliance processes.
Skills & Competencies:
o Strong analytical and problem-solving skills.
o Excellent communication and documentation abilities.
o Ability to manage multiple projects and meet deadlines.
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