Regional Regulatory Affairs Manager

Institut Rosell-Lallemand Inc.; Montreal; On-site; CAD 80,000 - 120,000; Full time

Job summary

A leading company in Montreal is seeking a Regional Regulatory Affairs Manager to oversee registration and compliance for agricultural products in LATAM. The role requires strong regulatory knowledge and project management skills, along with the ability to communicate effectively across various teams. Candidates must hold a Master's degree in a relevant field and be proficient in English, Spanish, and Portuguese.

Benefits

Career development opportunities

Supportive work environment

International exposure

Qualifications

• Strong understanding of regulatory requirements for biological products.
• Experience in dossier preparation and managing regulatory submissions.
• Proficiency in English, Spanish, and Portuguese.

Responsibilities

• Oversee product registration activities for LPC portfolio in LATAM.
• Manage compliance with local and regional regulatory standards.
• Collaborate with internal departments and external stakeholders.

Skills

Project Management

Problem Solving

Communication

Regulatory Knowledge

Team Collaboration

Education

Master's degree in agricultural sciences or similar

Industry-recognized certifications in regulatory affairs

Tools

Microsoft Office

Sharepoint

Database applications

Job description

The Regional Regulatory Affairs Manager plays a key role in managing all aspects of registration activities for LPC products in LATAM, and act as a link between the company and regulatory authorities, ensuring that products are developed, manufactured, commercialized, marketed and distributed in compliance with all appropriate legislations.

Main mission & responsibilities :

Product registration and compliance management :

• Oversee, plan and manage all aspects of product registration activities for the LPC portfolio of plant protection products in LATAM.
• Manage the entire to product registration process, including the preparation of new products dossiers, amendments, renewals, research authorizations), developing registration strategies, and ensuring compliance with local and regional regulations;
• Oversee registration renewal and maintenance activities;
• Monitor the regulatory environment, adapt to new data requirements, and communicate updates to relevant functions;
• Manage the development of product dossiers, including efficacy, safety (tox, ecotox), and other data from internal or third-party entities;
• Manage activities related to the legalization of the genetic heritage of LPC, following up and carrying out the processes approved by the external consulting and validation of the Board via National System of Management of Genetic Heritage and Associated Traditional Knowledge (SISGEN);
• Identify potential regulatory risks and develop mitigation strategies. Monitor post-market activities and manage regulatory compliance issues proactively.
• Oversee and monitor the budget for product registration activities in LATAM.
• Support the development of labels, leaflets, and packaging in accordance with the information provided by regulatory agencies and validate the technical and regulatory information, monitoring the entire process of creation and production with the sectors and suppliers involved ensuring that they meet the standards established;
• Support the S&OP and Product Management functions on labeling and packaging of products in compliance with relevant regulations and approvals;
• Work with S&OP to manage actions related to import / export requirements of products and microorganisms;
• Maintain accurate and up-to-date regulatory documentation. Prepare regulatory reports and dossiers as required;
• Assist in the development of a regulatory archive and documentation in SharePoint.

Communication and support :

• Work closely with product development, quality assurance, marketing, and other relevant internal departments to ensure regulatory requirements are met throughout the product lifecycle, obtain information for regulatory dossiers and reply to regulatory inquiries;
• Manage contracts with research institutions and third parties that involve product development, sharing of intellectual property, and technology transfer;
• Support local marketing with label development, creation of promotional marketing materials and representation at trade shows;
• Provide direct support and guidance to Field Solutions on the planning, conduct and report generation for field trails intended for regulatory purposes;
• Represent the company at conventions, seminars, conferences, and congresses, and actively participate in committees, task forces and business development trainings in relevant trade associations;
• Engage in lobbying and advocacy with regulators to improve registration processes for biologicals.

Team management :

• Manage the team including recruitment, performance evaluation, training, professional development, etc.

Internal and external relations :

• Interact with all LPC departments and represent Lallemand with regulators and in trade association activities specific to LATAM.

Technical skills

Required

• Strong understanding of regulatory requirements, guidelines and standards for the regulation of Biological products.
• Knowledge of regulatory data requirements and dossiers for microbial products is a strong asset
• Experience in dossier preparation, managing regulatory submissions and applicable platforms, interfacing with regulators, and problem-solving
• Ability to extract relevant information from research, study reports and scientific literature and summarize it into dossiers
• Demonstrated ability to manage, execute, and complete assigned projects
• Proficient in Microsoft Office, Sharepoint, and database applications
• Proficiency in written and verbal English, Spanish and Portuguese
• Master's degree in agricultural sciences, agronomy, biochemistry, microbiology, biology, environmental science or similar;

An asset

• Industry-recognized certifications in regulatory affairs

Personal abilities

Required

• Ethical and honest
• Sense of initiative, autonomy, and Proactive in making suggestions for improvement
• Organized, reliable, and detail-oriented, adept at juggling and prioritizing multiple tasks simultaneously while maintaining focus on essential details and deadlines
• Cross-functional team player : Capable of collaborating with internal and external stakeholders and adapting to changing conditions and unexpected obstacles
• Able to learn quickly on the job and stay updated with the latest regulatory requirements and technologies.

Organization

Lallemand is a privately held Canadian company founded in the late 19th century, which develops, produces, and markets microorganisms for various markets. The administrative offices of the parent company are in Montreal, Canada. Today, Lallemand employs more than 5,000 people working in more than 45 countries on 5 continents.

Yeasts, bacteria, fungi : microorganisms have always lived in harmony with plants since their origin and are now recognized for their multiple agronomic benefits. As a world specialist in microorganisms, Lallemand Plant Care carefully selects strains for agricultural use, to improve the nutrition, health, and productivity of plants.

Lallemand Plant Care is a growing business unit and offers many opportunities for career development and professional development on a local and international scale. Joining the Lallemand Plant Care team means collaborating with people who work passionately to develop sustainable, efficient, and clean solutions for agriculture professionals, horticulture, green spaces, and the forestry sector. We regularly recruit new talent from around the world to support our growth and our sales, logistics, marketing, production and research and development efforts.

Please take note that accommodations will be provided in all parts of the hiring process. Applicants need to make their needs known in advance.

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