Ecotox Specialist

PI Rajasthan, India
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Career Opportunities: Ecotox Specialist (10209)

Requisition ID 10209 - Posted  - Regulatory - India - Udaipur

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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.
  • 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

  • Strong 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

 

 

 

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

 

 

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