About this role
Job Overview
Reporting to the Head of Production, the Regulatory Affairs Specialist is responsible for supporting regulatory compliance and product registration activities for Koppert Canada, including regulatory submissions, renewals, documentation management, trial coordination, and regulatory communications. Working closely with Corporate Regulatory, Business Development, AgDev, regulatory authorities, and external partners, this role helps ensure regulatory obligations are met, registrations remain current, and regulatory information is accurately maintained to support ongoing compliance and market access.
Position Competencies
- Regulatory Compliance
- Registration & Portfolio Support
- Regulatory Trial Support
- Stakeholder & Regulatory Communications
- Processes & Continuous Improvement
Summary of Functions
Regulatory Compliance
- Prepare, submit, and maintain registrations, permits, amendments, notifications, and renewals with PMRA, CFIA, OMRI, NAPPO, EcoCert, and other applicable regulatory bodies.
- Track registration status, permit renewals, maintenance fees, and ongoing regulatory obligations.
- Update, maintain, and organize labels, SDSs, Technical Information Sheets, Letters of Assurance, and other regulatory documentation.
- Monitor regulatory updates and communicate relevant changes to internal stakeholders.
- Coordinate communications with regulatory agencies and support responses to regulatory requests and inquiries.
- Maintain regulatory calendars and ensure registrations, permits, certifications, and renewals are completed within required timelines.
Registration & Portfolio Support
- Support regulatory registration activities by gathering, organizing, and maintaining regulatory data, documentation, and submission materials as directed by regulatory leadership.
- Collaborate with Business Development, Corporate Regulatory, AgDev, and other stakeholders to support registration priorities and resource planning.
- Maintain product pipeline, registration roadmap, and gap analysis documentation to support strategic planning (as directed).
Regulatory Trial Support
- Collaborate with Koppert Global, CROs, universities, and other partners to coordinate trials supporting registrations.
- Coordinate regulatory trial activities and maintain supporting documentation required for registrations and label expansions.
- Assemble and maintain data and supporting information for regulatory dossiers, registration packages, and label expansions.
Stakeholder & Regulatory Communications
- Respond to customers, suppliers, consultants, and regulatory information requests in a timely manner.
- Distribute any regulatory documentation, while ensuring confidentiality requirements are met.
- Ensure labels, technical information, marketing materials, and website content align with regulatory requirements.
Processes & Continuous Improvement
- Participate in global regulatory projects and collaborative initiatives across Koppert entities.
- Develop and maintain SOPs, templates, and documentation systems to support accessibility and consistency across teams, as directed.
- Track regulatory projects, budgets, timelines, and status updates and communicate progress to relevant stakeholders.
Core Competencies
General Competencies and Qualifications
Successful candidates in the Regulatory Affairs Specialist position must possess:
- Diploma or Degree in Agriculture, Horticulture, Biology, Microbiology, Environmental Sciences, or a related scientific discipline.
- 2+ years of experience in regulatory affairs, compliance, quality assurance, regulatory administration, or regulatory coordination.
- Experience working with PMRA, CFIA, OMRI, EcoCert, or similar regulatory agencies and certification programs is preferred.
- Demonstrated ability to independently manage registrations, renewals, regulatory projects, and multiple priorities with minimal supervision.
- Strong organizational, record management, communicatio