Regulatory Affairs Manager, Americas

Lesaffre International; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with employer match

11 paid holidays

Job summary

Gnosis by Lesaffre, a division of Lesaffre, seeks a Regulatory Affairs Manager, Americas to lead regulatory strategy for the US, Canada, and LATAM markets. You will partner with Sales, Marketing, Operations, Quality, Medical Affairs, and R&D to enable speed to market while ensuring global compliance.

Travel up to 40% across the Americas is expected. The role requires strong DSHEA knowledge, experience with claims, and cross-functional leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.
• 7–10 years of regulatory affairs experience in nutraceuticals, dietary supplements, or food ingredients.
• Strong expertise in U.S. dietary supplement regulation under DSHEA (FDA/FTC).
• Experience with Structure/Function Claims and labeling compliance.
• Ability to advise senior leadership and cross-functional teams.
• Willingness to travel 30–40% across the Americas; occasional global travel.
• English fluency required.
• Based in United States, preferably central or eastern time zones.

Responsibilities

• Develop Market Access: leverage existing dossiers to assess expansion opportunities and maximize regulatory data value in Canada.
• Support global regulatory projects for the Americas and coordinate with other regions.
• Provide regulatory guidance for US, Canada, and LATAM market requirements.
• Advise NORAM customers and commercial teams with on-the-ground regulatory support.
• Create regulatory guidance documents for NORAM team (Q&A, country guides, training).
• Participate in Global RA rhythm and Americas leadership cadence.
• Support LATAM regulatory matters with LATAM coordinator (70/30 split).
• Monitor regulatory risks and build NORAM regulatory watch.
• Collaborate with RA, Medical Affairs, Substantiation, Quality, and R&D teams.

Skills

Regulatory affairs

DSHEA knowledge

Claims development

FDA/FTC compliance

Cross-functional collaboration

Scientific communication

English fluency

Travel readiness

Education

Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field

Job description

Elevate the Future with Gnosis by Lesaffre

For over 170 years, Lesaffre has been a pioneering force in the world of fermentation, harnessing the power of microorganisms to transform industries from baking to healthcare. As a key global player, we've built a presence in 96 countries, employing 11,000 passionate innovators who share our unwavering commitment to excellence.

Driven by our core values of passion, respect, trust, entrepreneurship, and humility, we're constantly pushing the boundaries of what's possible. Our 3-billion euro enterprise collaborates with visionary customers, partners, and researchers to develop essential nutrients and bioactives that strengthen human health, optimize animal well-being, and improve plant nutrition.

Discover Gnosis

Gnosis by Lesaffre is a pioneering division of the Lesaffre Group that leverages the power of microorganisms and fermentation to create innovative nutritional actives, probiotics, and functional yeasts. Serving leading nutraceutical and pharmaceutical brands, Gnosis harnesses the latest biotechnology advancements to develop high-quality, science-backed ingredients that support optimal health and wellness.

With deep expertise in microbiology and fermentation, the Gnosis team collaborates closely with customers to formulate customized solutions, from probiotic strains to nutritional yeasts that enhance the nutritional profile of food and supplements. Committed to sustainability and quality, Gnosis creates solutions that deliver superior performance and align with the evolving demands of health-conscious consumers.

What We Offer

The opportunity to represent a passionate organization focused on innovation and sustainability Competitive compensation and comprehensive benefits starting on day one, including health, dental, vision, and 401(k) with employer match11 paid holidays The ability to leverage your expertise and make a tangible, meaningful impact on the business and our sustainability initiatives Opportunities for continuous growth and development, including the ability to take on new challenges and collaborate across our international business units

How You'll Contribute To Our Success

The Regulatory Affairs Manager, Americas will be a strategic and collaborative partner, embedded within the regional leadership team to drive growth and innovation. They will leverage deep regulatory expertise to provide guidance that enables speed to market while ensuring compliance with global standards. By working closely with cross-functional leaders across Sales, Marketing, Operations, Quality, Medical Affairs, and R&D, the Regulatory Affairs Manager will help the Americas region achieve its objectives. Additionally, they will represent the company's interests in external industry forums, such as the Council for Responsible Nutrition, bringing regulatory and scientific insights to shape the dialogue. This role is crucial in ensuring the Americas region's success by navigating the complex regulatory landscape, mitigating risks, and unlocking new opportunities for the business.

What You’ll do as our Regulatory Affairs Manager, Americas

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&A, 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.

Required qualifications:

• 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 qualifications:

Master’s degree is a plus. Knowledge of Canadian and LATAM regulatory frameworks is preferred. Fluency in Spanish and/or Portuguese is a bonus.

Lesaffre provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.