Ecotox Specialist
Apply NowCareer 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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