Lesaffre North America · 3 hours ago
Regulatory Affairs Manager, Americas
United States
Full-time
Hybrid
Senior Level
7+ years expLesaffre North America is a pioneering force in the world of fermentation, committed to innovation and sustainability. The Regulatory Affairs Manager, Americas will be responsible for providing regulatory guidance to ensure compliance across the Americas region while driving growth and innovation through collaboration with cross-functional teams.
Food and BeverageFood DeliveryManufacturing
Responsibilities
Develop Market Access:
Leverage existing ingredient core dossiers to assess expansion opportunities and maximize the regulatory data value in the Canadian market
Support global regulatory projects and initiatives for the Americas
Work in close partnership with the regulatory team in other geographic regions to optimize the usage of existing data and facilitate market access
Support Health Claim Development:
Engage with the RA expert team to provide insights on the customer's business environment and competitor practices in order to contribute to the development of US-compliant structure function claims
Leverage expert-developed data to assess health claim opportunities in Canada
Provide Regulatory Guidance and Support:
Executes and interprets regulatory frameworks regionally, ensuring full alignment with global policies while tailoring implementation to meet U.S., Canadian, and LATAM market requirements
Actively engage with NORAM customers and commercial teams in the US and Canada by providing on-the-ground regulatory support and guidance adapted to the unique requirements of each local market
Advise customers on labeling and compliance in alignment with global frameworks and regional regulatory requirements
Represent the regulatory function and offer tailored RA inputs to contribute directly to the customer's projects
Participate in US and Canada meetings with customers and Key Accounts
Develop relevant regulatory guidance documents for the NORAM commercial team (e.g., Q&As, country guides, and training)
Actively participates in both the Global Regulatory Affairs operating rhythm and the Americas Regional Leadership Team cadence, ensuring two-way communication, knowledge sharing, and alignment of global and regional priorities
Manage, guide, and support the Scientific Technical Coordinator- LATAM to ensure effective market access and compliance in LATAM on all scientific technical matters bridging across Regulatory Affairs, Medical Affairs, Substantiation, Quality, and R&D (LATAM role allocation is ~70% regulatory and ~30% cross functional scientific support)
Collaborate closely with Scientific Technical Coordinator- LATAM to identify and address emerging regulatory risks and challenges and communicate to regional leadership team accordingly
Regulatory Impact Assessment:
Analyze the regulatory impact and customer implications of change control
Build Regulatory Intelligence:
Understand the regulatory landscape in US and Canada
Conduct regulatory watch in the Americas region and share the information through a dedicated process with global and other teams
Develop insights through competitor analysis and on-site customer visits
Develop deep insights into the NORAM competitive landscape by conducting comprehensive competitor analysis and fostering close relationships through on-site customer visits
Develop a NORAM regulatory watch as part of the RA & IP strategy
Partner with the NORAM commercial and marketing teams to leverage this localized intelligence and shape collaborative regulatory strategies that support our NORAM customers' market position
Share key findings from this market intelligence with the RA & IP teams to influence regulatory strategies across other markets
Ensure Compliance:
Ensure marketing document compliance by reviewing customer-facing materials developed for NORAM for regulatory accuracy
Support regional compliance assessment and documentation aligned with global regulatory standards
Support and manage the SDS for US market
External Network Development:
Represent Gnosis as the liaison to professional associations in the US and Canada, contributing to the development of an external regulatory network
Engage directly with local NORAM lawyers and consultants to share insights and information that strengthen the RA department's knowledge and capabilities
Decide on the persons to be contacted in case of customer questions
Other duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Regulatory Affairs, or related field
7–10 years of regulatory affairs experience in nutraceuticals, dietary supplements, consumer health, or food ingredients
Strong expertise in U.S. dietary supplement regulation under the Dietary Supplement Health and Education Act (DSHEA), with proven ability to navigate FDA and FTC requirements
Hands-on experience with Structure/Function Claims, Supplement Facts labeling, and related compliance frameworks
Deep understanding of how a premium ingredient supplier supports customer partners in regulatory compliance while not holding direct accountability for finished product labels
Demonstrated success advising senior leadership and cross-functional teams on regulatory matters
Proven track record of managing claims development, submissions, and compliance across multiple markets
Strong ability to interpret and communicate scientific/regulatory information for commercial application
Must be based in the United States preferably in a central or eastern time zone and be able to work cross-functionally across time zones
English fluency required
Ability to travel 30-40% of the time across the Americas, with occasional global travel to Europe
Preferred
Master's degree is a plus
Knowledge of Canadian and LATAM regulatory frameworks is preferred
Fluency in Spanish and/or Portuguese is a bonus
Benefits
Competitive compensation and comprehensive benefits starting on day one, including health, dental, vision, and 401(k) with employer match
11 paid holidays
Company
Lesaffre North America
Since 1853, Lesaffre and Red Star have used their passion and expertise to bring superior yeast & ingredients to the commercial baking industry.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Amanda Groh
Talent and Global Mobility Partner
Carrie Harmeyer
Executive Assistant to CEO
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