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Efate Specialist

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Job Description - Efate Specialist


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 New 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



 


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