About This Role
The Regulatory Affairs Specialist supports regulatory compliance and product registration for Koppert Canada, reporting to the Head of Production. This role involves managing regulatory submissions, renewals, documentation, trial coordination, and communications, working with various internal and external partners to ensure compliance and market access.
Responsibilities
- 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
- 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)
- 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
- 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
- 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
Requirements
- Diploma or Degree in Agriculture, Horticulture, Biology, Microbiology, Environmental Sciences, or a related scientific discipline
