Regulatory Affairs Specialist - Europe

Main Functions

Grow into Regulatory Affairs Specialist at Lallemand Plant Care in Europe : Join our team and an exciting business!

The Regulatory Affairs Specialist plays a key role in all aspects of registration activities for LPC products in Europe, 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. The main responsabilities are:

Product registration and compliance management

Collaborate on 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.

Contribute to the development of product dossiers, including efficacy, safety (tox, ecotox), and other data from internal or third-party entities.

Support Supply Chain & Logistics and Product Management on product labeling and packaging compliance.

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 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.

Assist in the development of a regulatory archive and documentation in SharePoint.

Internal and external communication and support

Communicate with internal departments (R&D, Quality Assurance, Technical Marketing, etc.) to obtain information for regulatory dossiers and reply to regulatory inquiries.

Contribute to contracts management with research institutions and third parties that involve product development, sharing of intellectual property, and technology transfer.

Represent the company at conventions, seminars, conferences, congresses, and actively participate in committees, task forces and business development trainings with regulators and relevant trade associations specific to Europe.

Collaborate in lobbying and advocacy with regulators to improve registration processes for biologicals.

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.

The Regulatory Affairs Specialist interacts with all internal LPC departments and external collaborators (including suppliers, regulators, third-party consultants, research laboratories and external stakeholders).

Technical skills required

Bachelor’s degree in sciences (fields such as agricultural sciences, agronomy, biochemistry, microbiology, biology, environmental science or similar). Masters degree is preferred

5+ years of experience in similar function(s)

Knowledge of and experience with the regulatory frameworks in Europe

Experience in the preparation of dossiers, regulatory submissions, and interface with regulators

Proven ability to extract relevant information from research, study reports and scientific literature and summarize it into dossiers

Experience with submission platforms in Europe

Demonstrated ability to execute, manage and complete assigned projects

Proficient in Microsoft Office, Sharepoint, and database applications

Advanced proficiency in written and spoken English

An asset

Knowledge of and experience in regulatory data requirements and dossiers for microorganism-based products for agriculture is a plus

Personal abilities required

Ethical and honest

Critical thinking, and reflective with excellent problem-solving skills; Analytical skills and detail-oriented

Sense of initiative; Autonomous; Proactive in making suggestions for improvement

Strong communication and interpersonal skills (written and spoken); Excellent writing skills

Good time management skills; Organized and reliable; Adept at juggling and prioritizing multiple tasks simultaneously while maintaining focus on essential details and deadlines

Cross-functional team player able to collaborate with internal and external stakeholders

Self-aware, reflective, and able to learn from mistakes; Able to learn quickly on the job

General criteria required

Be located near a Lallemand Plant Care office in Europe

Be able and willing to travel approximately up to 20% of travel per year

Be able to travel by car or plane

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.