Assistant Manager Regulatory and Toxicology

3 days ago

Pune, Maharashtra, India Auxilife scientific services pvt ltd Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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: -

  1. PhD or Masters degree in Toxicology or related field.

  2. 1 to 4 years of experience in regulatory affairs or toxicology within the agrochemical /pharmaceutical industry or other related area

  3. Knowledge of Regulatory framework for agrochemical, disinfectants, biocide and food contact material products.

  4. Experience in compiling regulatory dossiers and toxicology reports. - Familiarity with GLP and regulatory compliance processes.

  5. 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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