Position Description

Business Division:

PI-Int. Agri

Department:

Global Development

Location:

India

Position Title:

Ecotox Specialist

Level:

tbd

Reporting to (Title):

Lead Regulatory LATAM & Global Chemistry

Position Purpose

The role holder shall report to the Lead Regulatory LATAM & Global Chemistry and shall be responsible for:

- Providing scientific and regulatory expertise in ecotoxicology to support the development, registration, and lifecycle management of crop protection products.

- Ensures that ecotoxicological risk assessments comply with global regulatory requirements.

- Provide scientific input to product stewardship strategies and sustainability initiatives.

- Support internal and external scientific discussions, including meetings with regulatory authorities and contract research organizations (CROs).

- Monitor and interpret changes in international ecotoxicology regulations and guidance documents.

- Monitoring and constant improvement of collaboration with CROs concerning quality and timeline.

- The interaction with the respective regulatory authorities, pre- and post-submission.

- Consulting of Research for Phase 1 and Phase 2 chemistry projects concerning regulatory requirements and constraints for upcoming pipeline candidates.

- Support of the preparation of Phase 3 decisions.

Strategic Responsibilities

- Design, review, and interpret ecotoxicological studies for active ingredients and formulated products, including acute, chronic, and higher-tier studies.

- Ensure regulatory compliance with authorities such as IBAMA (Brazil), EPA (US), CIBRC (India).

- Provide scientific justification for waivers, read across, and bridging approaches.





- Perform environmental risk assessments for non-target organisms (aquatic organisms, birds, mammals, bees, arthropods, soil organisms, and plants).

- Evaluate study reports conducted according to OECD, EPA, EU, IBAMA, CIBRC and other internationally recognized guidelines under GLP.

- Support data gap analyses and define ecotoxicology testing strategies aligned with regulatory and product development timelines.

- Prepare and review ecotoxicology sections of regulatory dossiers for product registrations, renewals, amendments, and equivalence submissions.

Operational Responsibilities

- Support responses to regulatory questions, deficiency letters, and data requests related to ecotoxicology.

- Contribute to risk mitigation proposals, label restrictions, and environmental protection measures.

- Provide regulatory guidance into projects, especially Phase 2 and 3 but also advanced Phase 1, regularly join respective project and committee meetings.

- Interact with regulatory authorities in key countries pre- and post-submission to position PI candidates and evaluate potential risks in the approval process at earliest possible time.

- Closely collaborate with CROs on progress of regulatory studies, upcoming issues and respective impacts on risk assessments.

Financial Responsibilities





People Responsibilities

Education Qualification

- Extensive experience in Ecotoxicology, Environmental Sciences, Biology, Toxicology, Ecology, or a related scientific field.

- Degree in a related subject, e.g. agriculture, chemistry, biology.

Work Experience

Experience in environmental safety, preferably within the crop protection industry or regulatory consulting for > 5 years

Industry to be Hired from

Agrochemical, Seeds & Traits, Agronomy

Functional Competencies

- Robust knowledge of regulatory ecotoxicology requirements and risk assessment frameworks

- Proven experience in ecotoxicology within the agrochemical, pesticide, or crop protection industry.

- Experience with global registration processes and regulatory submissions is highly desirable.

- Excellent scientific writing skills for regulatory dossiers.

- Ability to critically evaluate study quality (GLP compliance, guideline adherence).

Interaction Complexity and Team Work

Interaction

Frequency

Purpose of Interaction

Internal:

- Other PI Development functions

- Local Development Teams

- R&D;

- CSM

As and when required

• Work closely with environmental fate, toxicology, regulatory affairs, R&D;, and product stewardship teams

• support dossier preparations and submissions globally

- Consulting strategy in Phase 1 and 2

- Closely collaborate with CROs on progress of regulatory studies, upcoming issues and respective impacts on risk assessments

External:

- Regulatory authorities

- CROs

• Discuss dossier pre-/post-submission

• Steer study execution and timelines

📌 Ecotox Specialist (Udaipur)
🏢 Important Company of the Sector
📍 Udaipur