Career Opportunities: Efate Specialist (10208)

Requisition ID 10208 - Posted  - Regulatory - India - Udaipur

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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).
• 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 New active ingredients, technical equivalence and Formulated products.
• 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

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

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