Position Description

Business Division:

PI-Int. Agri

Department:

Global Development

Location:

India

Position Title:

E-fate 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:

- Design, select, and oversee environmental fate and degradation studies in accordance with international guidelines (e.g. OECD, EPA, IBAMA).

- Provide expert interpretation of laboratory and field studies, including Soil degradation OECD 307); Aquatic sediment studies (OECD 308); Anaerobic soil metabolism (OECD 311); Adsorption/desorption (OECD 106), Hydrolysis (OECD 111), Photolysis in water and soil (OECD 316), Volatilization and dissipation studies.

- Evaluate degradation kinetics (DT50, DT90), metabolite profiles, mass balance, and pathway elucidation.

- Support higher-tier studies and risk refinement when required (e.g. field dissipation, modelling).

- 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

Operational Responsibilities

- Prepare, review, and compile environmental fate sections of regulatory dossiers for Recent active ingredients, technical equivalence and Formulated products.

- Ensure regulatory compliance with authorities such as IBAMA (Brazil),



EPA (US), CIBRC (India).

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

- Respond to regulatory questions, deficiency letters, and data gap requests.

- Support exposure assessments using fate data and modelling tools.

- Provide input for environmental risk assessments (ERA) for soil, surface water, groundwater, and sediment compartments.

- Collaborate with ecotoxicology and residue experts to support integrated environmental risk assessments.

- Manage environmental fate studies at CROs and research institutions, including Protocol review, Study monitoring & Data evaluation and reporting.

- 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 Environmental Sciences, Chemistry, Soil Science,



Environmental Chemistry, Agronomy, or related discipline

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

Work Experience

Experience in environmental fate and behaviour of agrochemicals, preferably within the crop protection industry or regulatory consulting for > 5 years

Industry to be Hired from

Agrochemical, Seeds & Traits, Agronomy

Functional Competencies

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

- Excellent scientific writing skills for regulatory dossiers.

- Experience with OECD, EPA, EU, CIBRC and Latin American regulatory frameworks

- Expert knowledge of environmental fate study design, data interpretation, and regulatory expectations.

- Strong understanding of degradation kinetics, metabolite relevance, and environmental exposure pathways.

- Familiarity with environmental fate modelling tools and higher-tier refinements.

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

• Collaborate with ecotoxicology and residue experts to support integrated environmental risk assessments

• 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

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