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Job Post Details
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Détails du poste
Description complète du poste
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, communication, and attention-to-detail skills.
- Experience or education related to horticulture, agriculture, biologicals, biopesticides, or microbiology is considered an asset.
- Valid Driver's License and ability to travel as required.
Technology Competencies
Regulatory Affairs Specialist must be able to adapt on the fly using the technology provided to them. This includes interactions in and out-of-office. Successful candidates must have:
- Intermediate/Advance knowledge of Microsoft Office (Excel, Word, PowerPoint etc.)
- Adept at utilizing smart phone technologies; text, photo sharing, messenger groups etc.
- Experience navigating PMRA and CFIA portals and managing submissions and profiles (an asset).
Behavioural Competencies
These are a combination of skills, attributes, and behaviours, which are directly related to the successful performance on the job.
- Maintain a high degree of integrity and ethical behaviour in all business activities and decisions
- Set personal standards of conduct that meet or exceed company or legal requirements
- Keeps confidences, admits mistakes, and does not misrepresent themselves for personal gain.
- Models and reinforces ethical behaviour in self and others.
- Maintains Koppert standard of work as deemed fit by Head of Scientific Development
- Protects and demonstrates company vision of excellence
- Follows accountability chart as prescribed by Head of Scientific Development
- Dedicated to meeting the expectations and requirements of internal and external stakeholders.
- Follows through on identified problems until resolution.
- Establish and maintain harmonious professional relations by demonstrating respect for and sensitivity to others.
- Facilitate effective brainstorming while bringing good, creative ideas out of others.
- Develop and maintain effective working relationships with team members, internal partners, customers and others using strong interpersonal skills. Obtain cooperation of others, seek and encourage win-win alternatives.
Company Values
We partner with Nature:
- We have a deep respect for nature. Nature was here first and will always find a way. We use nature as a tool against itself to provide ethical, health-conscious ways to produce, maintain, and promote growth.
We Work for Growers:
- Our growers are key figures within our business. We feel a strong responsibility to share our expertise to serve them, and in doing so, our communities in the best way possible. Without our growers, there is no Koppert.
We Keep Improving:
- Just as the world we live in is constantly changing and innovating, so to does our company. We believe that constant innovation is the only way to keep a growing company that employees, our growers, and our world can benefit from. Without innovation, we cannot hope to continue.
We Build Global Networks:
- Collaboration is in our DNA. We cannot do this on our own. We know that in order to get closer to realizing our mission and vision, we need to work together. That’s why, in partnership with 100 countries around the world, Koppert’s name can continue to grow, globally.
We are Family:
- We care, respect, and value each other. We are welcoming and open. Within Koppert, we are united through values and a strong belief in biological solutions and sustainable growing practices. We understand that tough times may come, but through a familial bond and care for nature, we believe that anything can be overcome. We have your back!
Work Environment
What you can expect
- This position involves a hybrid working model. Most of the time, your work will involve an office space, and part of the time, your work will consist of field settings.
- This position requires to be physically able to endure outdoor or indoor climates including hot or cold extremes and walking on uneven surfaces. Regular exposure to pollinators (bumblebees) may occur.
- Ability to work flexible hours or weekends as needed.
Pay: $60,000.00-$65,000.00 per year
Benefits:
- Casual dress
- Company events
- Dental care
- Employee assistance program
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
Education:
- Bachelor's Degree (preferred)
Experience:
- Regulatory Affairs : 2 years (required)
Licence/Certification:
- Driving Licence (required)
Work Location: In person