Regulatory Affairs Manager

Lesaffr; New York, Chicago (NY, IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Health, dental, vision, and 401(k)

11 paid holidays

International reach and growth as a人

Growth as a people manager

Job summary

Lesaffre, including its Gnosis by Lesaffre division, seeks a Manager of Regulatory Affairs to lead the Americas regulatory strategy, ensuring US and Canadian market access and compliant labeling practices. The role partners with global teams to align regulatory efforts and drive business growth.

Ideal candidates bring 7–10 years in nutraceutical regulatory affairs, DSHEA expertise, and strong leadership skills, with travel 30–40%. Based in the United States, preferably NYC or Chicago area.

Qualifications

• Bachelor’s degree in life sciences, regulatory affairs, or related field.
• 7–10 years of regulatory affairs experience in nutraceuticals, dietary supplements, or consumer health.
• Strong expertise in U.S. dietary supplement regulation under DSHEA with FDA/FTC experience.
• Hands-on experience with structure/function claims, labeling, and related compliance.
• Willingness to travel 30–40% of the time.
• Based in the United States, preferably in the New York City or Chicago metro areas.

Responsibilities

• Lead regulatory strategy and global alignment for the Americas.
• Regulatory guidance and support for US/Canada markets and customers.
• Develop market access and labeling strategies.
• Mentor LATAM team and coordinate with cross-functional partners.
• Represent the company in industry forums and customer meetings.

Education

Bachelor’s degree in life sciences, regulatory affairs, or related field

Job description

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 match
• 11 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 international reach, the ability to grow as a people manager, and gain expertise in regions such as Canada and LATAM

How you'll contribute to our success

You won’t just navigate regulations—you’ll redefine what’s possible. As our Manager, Regulatory Affairs, you’ll be the strategic engine behind our Americas growth, turning compliance into a competitive advantage. Your expertise in DSHEA, FDA, and FTC requirements will unlock new markets, guide leadership on high-stakes decisions, and empower our teams to innovate with confidence. From supervising our LATAM coordinator to representing Gnosis in industry forums (like CRN), you’ll bridge science and business, ensuring our regulatory strategy fuels our customers’ success—and ours. If you’ve got nutraceuticals or dietary supplement experience, you’ll hit the ground running, mentoring teams and shaping the future of health in a fast-moving, high-impact environment.

What you’ll do as a Manager, Regulatory Affairs

• Safety
• Demonstrate an unwavering commitment to Lesaffre's safety-first culture by strictly following all safety protocols and participating in required safety programs
  • As a leader, has impact on others by setting the example for others to follow
  • Market access development
• Champion global regulatory projects for the Americas
• Collaborate with global teams to optimize data usage and streamline market access
• Analyze customer business environments and competitor practices to develop US-compliant structure/function claims
• Evaluate health claim opportunities in Canada using expert-developed data
• Regulatory guidance
• Implement regional regulatory frameworks while ensuring global alignment
• Deliver on-the-ground regulatory support to US and Canadian customers and commercial teams
• Guide labeling and compliance per global and regional requirements
• Lead regulatory function in customer projects
• Engage in customer and key account meetings
• Create regulatory guidance documents (Q&As, country guides, training)
• Contribute to global regulatory affairs and Americas regional leadership team meetings
• Manage and develop Scientific Technical Coordinator-LATAM on regulatory and scientific matters
• Mitigate regulatory risks through collaboration with LATAM coordinator
• Regulatory intelligence
• Monitor US and Canadian regulatory landscape
• Conduct Americas regulatory watch and disseminate insights globally
• Generate competitive insights through analysis and customer visits
• Align with commercial/marketing teams on regulatory strategies
• Communicate market intelligence to global RA & IP teams
• Compliance
• Participate in the evaluation of impact of control change
• Ensure regulatory accuracy within customer-facing materials
• Facilitate regional compliance assessment and documentation
• External relations
• Serve as company representative in US and Canadian professional associations
• Build relationships with local lawyers/consultants to enhance regulatory affairs knowledge
• Other duties as assigned

At Gnosis, we move fast, think bigger, and make things happen. This isn’t a role for those who want to check boxes—it’s for regulatory strategists who wear multiple hats with ease, thrive when challenged, and leverage their expertise to drive real change. You’ll collaborate across teams, tackle complex problems with creativity, and see your work directly impact our customers and business. If you’re the kind of person who asks “why not?” instead of “why?”, who turns obstacles into opportunities, and who wants to grow while making a tangible difference, you’ll fit right in. Here, your knowledge, ingenuity, and passion won’t just be valued—they’ll be essential.

Required qualifications:

• Bachelor’s degree in life sciences, regulatory affairs, or related field
• 7–10 years of regulatory affairs experience in nutraceuticals, dietary supplements, or consumer health
• Strong expertise in U.S. dietary supplement regulation under the Dietary Supplement Health and Education Act (DSHEA), with proven ability to navigate Food and Drug Administration (FDA) and Federal Trade Commission (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 the New York City or Chicago metro areas and able to work cross-functionally across time zones
• Ability to travel 30-40% of the time across the Americas, with occasional global travel to Europe

Preferred qualifications:

• Master’s degree in an applicable field
• Knowledge of Canadian and LATAM regulatory frameworks
• Fluency in Spanish and/or Portuguese

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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.