Regulatory Affairs Specialist

Main Functions

Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist develops and executes regulatory activities that enable compliant market access and support sustainable business growth across Lallemand Bio-Ingredients.

The role prepares and maintains regulatory dossiers, assesses product and market requirements, monitors regulatory changes, and provides clear, practical guidance to cross-functional teams. The position is supporting regulatory activities, including dossiers for new product developments, innovation projects, product regional expansions, and compliance activities such as managing customer enquiries, reviewing supplier regulatory documentation, and ensuring compliance of enzyme products across relevant markets.

Regulatory market access and dossiers

• Assist the Regulatory Director in developing regulatory strategies and roadmaps for new and existing ingredients, including timelines, evidence requirements, risks, opportunities and submission routes.
• Prepare, and maintainhigh-quality regulatory dossiersand notifications, includingfood enzyme, Novel Food, GRAS and other territory-specific submissions, as applicable.
• Prepare responses to authority questionsand coordinate supporting evidence, expert input and cross-functional contributions throughout the review process.
• Perform regulatory data audits and gap analyses to identify the studies, testing, specifications and documentation needed to support safety, compliance and market access.
• Assess the regulatory status, permitted uses, labelling and market-access implications of conventional, novel, fermentation-derived and precision/GMO fermentation ingredients.

Regulatory intelligence and external engagement

• Monitor and interpret regulatory developments, guidance and emerging policy impacting the products and markets, and translate them into clear business implications and actions.
• Contribute to regulatory positions, public consultations and relevant tradeassociation or authority interactions, in coordination with the Regulatory Affairs Director and Regulatory Specialists within the team.
• Maintain awareness of cross-cutting topicssuch as claims,labelling, non-purified microorganisms, pesticides, packaging and sustainability-related regulatory requirements.

Business and cross-functional support

• Provide timely regulatory advice to R&D,Quality Assurance, Sales, Marketing, Supply Chain and other stakeholders for innovation projects, product changes, customer requests and business development.
• Collaborate with internal experts to collect, verify and consolidate technical, quality, safety and manufacturing information needed for regulatory assessments and dossiers.
• Review claims, labels, marketing communications, technical documents and customer-facing materials for regulatorycompliance.
• Support customer and QA documentation, including questionnaires, certificates, statements, declarations, safetydata sheets and regulatory position papers.

Documentation, systemsand team contribution

• Create and maintainaccurate regulatory records,reports, presentations, templates, databases and productdocumentation in accordance with team processes.
• Contribute to the digitalization, standardization and continuous improvement of regulatory tools, workflows and knowledge-management practices.

Technical skills

Required

• Scientific rigor, sound judgement and strong attentionto detail.
• Excellent planning, prioritization and ability to manage multipleprojects in parallel.
• Clear communication and effective cross-functional collaboration in an international environment.
• Proactive,pragmatic, adaptable and solution-oriented approach.
• Autonomy and accountability, combined with a strong team mindset..

Personal abilities

Required

• Master’s degree in food science, microbiology, biotechnology, biochemistry, regulatory science or anotherrelevant discipline.
• Minimum five years of relevant regulatory affairs experience, including regulatory assessments and/or dossier preparation.
• Previous experience with enzymes and/ or baking industry in a commercial or business environment, including interaction with customers and support for commercial, technical or application-related questions.
• Working knowledge of food chain regulatory frameworks in at least two major territories, with EU and US knowledge preferred; other international-market experience is an asset.
• Fluent in English with excellent technical and dossier-writing skills. French is an asset.
• Ability to interpret complex scientific and regulatory information and convert it into concise, business-relevant recommendations.
• Strong digital proficiency, including Microsoft 365 tools, databases and project-management or collaboration tools.

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 6,500 people working in more than 45 countries on 5 continents.

Lallemand's Bio-Ingredients business unit has decades of experience as a quality yeast producer for the savory, health, and biotech industries.

We produce a wide range of products including yeast extracts, inactive yeasts and their derivatives for flavour enhancers, enriched mineral and vitamin yeasts for the health supplement and health food markets, and high-grade yeast extracts for the biotech industry. These products are propelled across the globe thanks to our impressive reach and a large dedicated team that serves our customers worldwide.

The Bio-Ingredients team is proud of the strong partnerships it has forged with its clients, relying on trust and cooperation in order to develop custom solutions for each individual business. Check out the available career opportunities in North America and several European countries.

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