Job Description:
We are seeking a Regulatory Workflow Subject Matter Expert (SME) to provide advisory and compliance support to the development of a Project Governance Framework for an agriculture company. In this role, the SME will serve as a trusted advisor, providing expert guidance, assurance, and oversight to ensure that regulatory workflows across Seeds and Crop Protection are accurately interpreted and appropriately embedded into project governance processes.

During the design phase, the SME will review, challenge, and validate proposed processes to ensure they align with global, regional, and local regulatory requirements, ultimately safeguarding compliance, minimizing risk, and supporting faster, compliant pathways to market.

Key Responsibilities:

Regulatory Advice & Oversight

· Advise the project team on regulatory obligations, compliance expectations, and required controls across the product lifecycle (planning, execution, submission→ approval).
· Review proposed Project Governance Framework processes and workflows to ensure alignment with regulatory best practices, emerging regulations, and regional variances.
· Provide expert interpretation of global regulatory frameworks, including dossier expectations, stewardship requirements, data obligations, and labeling impacts.

Compliance Assurance

· Identify compliance gaps, risks, and control deficiencies within project workflows and recommend mitigation measures.
· Validate that all governance artifacts (stage-gate checklists, templates, decision logs, tollgate evidence) meet regulatory expectations.
· Ensure that critical regulatory deliverables (data packages, submission-ready dossiers, studies, field data, stewardship documentation) are correctly represented in the workflows.

Risk Management & Decision Support

· Advise on regulatory risks (e.g., delays, data gaps, emerging regulatory changes) and recommend decision points for escalation.
· Ensure regulatory risk assessments, early-signal indicators, and mitigation plans are integrated into framework materials.
· Support the project team in defining minimum evidence, quality expectations, and timing for regulatory contributions to major decisions.

Regulatory Governance Support

· Review RACI/DACI proposals to ensure regulatory roles, responsibilities, and decision rights are accurately reflected.
· Provide guidance on global-to-local handoffs and define where advisory sign-off steps are mandatory to maintain compliance.
· Partner with IT and process owners in an advisory capacity to ensure proposed systems and tools enable compliant workflows.

Required Qualifications

· 10+ years in Regulatory Affairs/Operations in agri-science (seeds, crop protection, biologicals) or adjacent regulated industries.
· Expertise interpreting and applying regulatory guidelines across multiple regions (e.g., North America, EMEA, LATAM, APAC).
· Strong understanding of stage-gate governance, regulatory evidence expectations, and risk management.
· Ability to articulate compliance expectations clearly to non-regulatory stakeholders.
· Skilled in reviewing and challenging process designs without assuming ownership of design activities.