The incumbent should reside in Ottawa, Ontario, or should live in southwest Ontario with the ability to commute occasionally to the Head Office in Mississauga.
MISSION
Your core mission is to coordinate major regulatory submissions to the PMRA (33%) and US-EPA (67%). You will coordinate internally between Sales & Marketing and Product Development to develop expectations, gather necessary information, and execute on regulatory priorities. In addition, you work with the Manufacturing
department to ensure production of registered pesticides meets regulatory requirements.
You will deliver on this mission by:
- Developing clear and effective regulatory strategies for assigned projects to ensure regulatory goals and objectives are achieved in an efficient and timely manner.
- Prompting preparation and submission of regulatory applications for new products (generally within 5 months of receipt of product candidate from Product Development team).
- Prompting preparation and submission of updated recipes and labels.
- Gathering information from internal stakeholders including input from Sales and Marketing, Product Development, and Regulators.
- Leading effective negotiations with regulatory agency stakeholders to achieve regulatory outcomes.
- Collaborating with industry trade associations to stay informed and up to date on regulatory trends.
Interacts with:
- Internally – Regulatory, Sales, Marketing, Business Development, Finance, Product Development, Research, QA/QC, Legal
- Externally – EPA/PMRA, Provincial and State Regulators,
External Consultants, Contract Research Organizations, Service Providers, Trade Associations
Accountability - In your first 12 months, you will:
- Regulatory strategy - Create individual product regulatory strategies as assigned that ensure product management objectives are met
- Regulatory submissions - Prepare and submit regulatory dossiers to relevant regulatory agency(s) for assigned development projects. Includes coordination of the development of data and the identification of data compensability
- Collaboration - Deliver regular target audience appropriate communications that elicit a clear understanding of technical regulatory requirements and timelines to non-regulatory audiences
- Industry collaboration - Regularly attend in-person or virtual industry trade associate meetings and workshops to stay informed and up to date on regulatory trends
Specific Duties & Responsibilities:
- Develops regulatory/registration strategies and conducts all associated activities for designated active ingredients and products for the Canadian, US, including California markets. Assess data requirements to support regulatory objectives and set data gap filling strategy.
- Plan and set up external studies with third‐party cooperators to develop data to meet regulatory requirements. Defines work scope and manages output of third‐party consultants assisting with regulatory affairs, product chemistry, toxicology, environmental fate, and or ecological effects.
- Oversee third‐party studies, analyze results, and prepare detailed reports, note conclusions, and make recommendations within the scope of the assignment to various audiences including team leads, managers, and other members of the team through weekly meetings, presentations, and technical reports.
- Participate in data compensation scoping.
- Prepare relevant registration packages for inert ingredients, and end use products for submission to PMRA and US-EPA. Ensure that packages are complete and accurate and are executed to agreed timescales according to business plan.
- Provides coaching, technical support and feedback to junior regulatory staff.
- Communicates and provides guidance and strategic advice on regulatory timelines to other departments, including product development and marketing. Ensures that all departments are aware of all relevant regulatory timelines, including prompt communication of changes in expected registration timing. Coordinates the review and submission of product labels, with support from other departments as required.
- Advises business regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.
- Collaborates with product development and is fully responsible to develop and implement strategies for product registration and regulatory stewardship.
- Represents Vive Crop in discussions and interactions with PMRA/US EPA and other regulatory agencies.
Negotiating directly with regulatory authorities regarding company’s regulatory actions and regulatory policy which affects Vive Crop’s business interests.
- Acts as the Vive Crop regulatory representative in industry association committees, providing detailed information to the business on any developments and proposing and agreeing on strategies to reduce any associated business risk.
- Reviews regulatory publications, keeping the business and team members apprised of new regulatory developments.
- Keeps up to date with the latest technical developments in the related area, including participation in Croplife Canada or other trade association meetings.
Skills & Experiences:
- Bachelor’s degree or diploma in related scientific discipline such as chemistry, biology, toxicology; Master’s or advance degree preferred but not essential.
- 4+ years related experience in a relevant field; most likely in the crop protection industry.
- Familiarity with regulatory laws, regulations, and rules specific to the company product lines. Familiarity with toxicology and environmental fate a must. Experience with pesticide value (efficacy) assessments would be a significant asset.
- Experience working with the PMRA is required and experience working with the US-EPA, other government agencies, or trade associations is beneficial.
- Strong negotiation skills with stakeholders to achieve outcomes beneficial to the business.
- Excellent literature and experimental research skills; data analysis and statistical skills.
- Strong analytical and problem-solving skills, creativity, and innovation, organizing and planning skills, ability to work under pressure in a multitasking environment, good project management skills, good oral and written communication skills to connect with all levels of the organization, very good interpersonal skills, team skills, leadership skills, propensity to continuous learning and experimenting.
- Possesses skill in determining alternatives that would correct a situation to comply with business standards and regulations.
- Very good computer skills including with spreadsheets, office programs and applicable software applications.
- Comfortable working in a fast-paced environment, with a high degree of urgency and responsibility.
- High ability to make decisions, influence others, and provide counsel on the spot, often without full information or context.
- Highly team-orientated but must be self-starter and able to work independently.
Requirements:
- Valid passport. Must have the ability to travel domestically and internationally.
- Travel up to 10%
For more information and to apply for this position, click here.