Regulatory Affairs Manager

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🕒 Julho 28

🌽 Illinois, New York – Remoto

🌽 Illinois – Remote 🗽 New York – Remote

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🚔 Conformidade

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Lesaffre North America

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 1853

🍽️ Alimentos e Bebidas

🏭 Manufatura

🧬 Biotecnologia

Food & Beverage • Manufacturing • Biotechnology

A Lesaffre América do Norte é um fornecedor de ingredientes e soluções para panificação comercial e uma subsidiária do Grupo Lesaffre. Com uma história enraizada na produção de fermento, a empresa fornece fermento, melhoradores de massa, extensores de vida útil, ingredientes para sabor e formulação, e serviços técnicos para panificadoras industriais, distribuidores de panificação, operadores de food service, padarias de supermercado e padeiros artesanais. A Lesaffre oferece suporte à formulação de produtos, expertise em eficiência de produção, opções de rótulo limpo e orgânicas, e marcas como Red Star Yeast, atendendo tanto clientes comerciais quanto padeiros domésticos.

Descrição

• Demonstrate an unwavering commitment to Lesaffre's safety-first culture by strictly following all safety protocols and participating in required safety programs • Drive expansion opportunities in Canada using existing ingredient dossiers • 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 • 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 • 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 • Participate in the evaluation of impact of control change • Ensure regulatory accuracy within customer-facing materials • Facilitate regional compliance assessment and documentation • Serve as company representative in US and Canadian professional associations • Build relationships with local lawyers/consultants to enhance regulatory affairs knowledge • Coordinate appropriate contacts for customer questions • Other duties as assigned

🎯 Requisitos

• 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) • 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

🏖️ Benefícios

• Competitive compensation and comprehensive benefits starting on day one, including health, dental, vision, and 401(k) with employer match • 11 paid holidays • 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