International Regulatory Operations Lead
Skills
- Deep knowledge of global regulatory frameworks for gene editing, GMOs, seed laws, biosafety, and phytosanitary trade.
- Proven track record securing seed/plant approvals across multiple jurisdictions.
- Experience with DUS/VCU testing, variety registration, and non-GMO declarations.
- Strong project leadership and cross-functional coordination skills.
- Hands-on operator able to manage filings, trial logistics, and partner onboarding.
- Excellent written and oral communication with regulators and commercial partners.
Responsibilities
- Lead end-to-end global regulatory operations for seed and plant variety launches, managing timelines and approvals across priority markets (LATAM, India, Africa, Australia, EU when accessible).
- Design and execute market-entry pathways including seed variety registration, DUS/VCU testing, and non-GMO declarations where applicable.
- Serve as primary project lead for regulatory submissions, coordinating Legal, Product Development, Commercial teams, and external consultants/CROs.
- Monitor evolving global regulations (gene editing, GMO classification, seed laws, biosafety, phytosanitary trade) and translate changes into actionable company strategies.
- Develop and maintain standardized regulatory playbooks, SOPs, and metrics to scale processes across crops and geographies.
- Oversee material movement compliance including import/export permits, phytosanitary requirements, and customs clearance for seeds and plant materials.
- Coordinate with commercial partners, CROs, and in-country growers to align regulatory approvals with trial and sales timelines.
- Engage with regulatory bodies to shape and expedite GTM processes for new technologies (e.g., true potato seed).
Education
- Bachelor’s degree in plant science, biology, agronomy, regulatory affairs, or related field required.
- Advanced degree (MS/PhD) in a relevant discipline preferred.
Benefits
- Competitive salary within posted range
- Equity/stock options
- Medical, dental, and vision insurance
- 401(k) or retirement savings plan
- Paid time off and holidays
- Professional development opportunities
Average salary estimate
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