Assistant Manager – Regulatory

3 days ago

Pune, Maharashtra, India Auxilife Scientific Services Pvt. Ltd. (a unit of GPC) Full time ₹ 8,00,000 - ₹ 24,00,000 per year

Location: Pune, Maharashtra Reports To: General Manager

Company Overview: Auxilife is a leading agrochemical research and regulatory solutions provider, focused on developing innovative crop protection products while ensuring compliance with regulatory requirements globally.

Position Summary: The Assistant Manager – Regulatory & Toxicology will support regulatory submissions and toxicological evaluations for crop protection products. This role involves coordination with teams, external CROs, clients and regulatory authorities for regulatory strategy and registration.

Key Responsibilities:

Regulatory Affairs:

  • Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products.
  • Liaise with client and regulatory authorities for approvals, clarifications, and queries.
  • Maintain up-to-date knowledge of regulatory requirements in India and international markets.
  • Support risk assessment and labeling compliance for products.

Toxicology & Safety Evaluation:

  • Review and interpret toxicology, Endocrine disruptors and ecotoxicology study reports.
  • Coordinate with external labs/CROs for conducting toxicological and ecotoxicology studies.
  • Maintain regulatory and toxicology databases, including study and regulatory guidelines.
  • Conducting literature search and QSAR analysis

Team Management / Leadership Responsibilities:

  • Mentor team for ensuring timely and accurate preparation of MSDS (Material Safety Data Sheets), literature review and QSAR analysis
  • Oversee the correct classification and labelling according to GHS, local regulations, and international standards.
  • Guide the team in managing regulatory registration processes of agrochemical, disinfectants, biocide and food contact material products.
  • Track regulatory changes and ensure the team is updated with the latest global guidelines relevant to chemical classification, labelling, and safety reporting.
  • Provide feedback and develop skill enhancement plans for team members in regulatory and toxicology functions.

Qualifications & Experience:

  1. PhD or master's 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.

Skills & Competencies:

  • Strong analytical and problem-solving skills.
  • Excellent communication and documentation abilities.
  • Ability to manage multiple projects and meet deadlines.

Version October 2025

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