出海雷达

法规事务经理

Regulatory Affairs Manager

职能支持限定地区(需当地身份)
公司Lesaffre
薪资未公开
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间18 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

与Lesaffre一起引领未来

170多年来,Lesaffre一直是发酵领域的先驱力量,利用微生物的力量改变从烘焙到医疗保健的行业。作为全球重要参与者,我们在96个国家设有业务,拥有11,000名充满热情的创新者,他们与我们一样致力于卓越的承诺。
我们以激情、尊重、信任、创业精神和谦逊为核心价值观,不断突破可能的边界。我们的30亿欧元企业与有远见的客户、合作伙伴和研究人员合作,开发关键营养素和生物活性物质,增强人类健康,优化动物福利,并改善植物营养。
了解Gnosis!
Gnosis by Lesaffre是Lesaffre集团的一个开创性部门,利用微生物和发酵的力量创造创新的营养活性物质、益生菌和功能酵母。服务于领先的营养补充品和制药品牌,Gnosis利用最新的生物技术进步,开发高质量、科学支持的成分,以支持最佳的健康和福祉。凭借在微生物学和发酵方面的深厚专业知识,Gnosis团队与客户紧密合作,制定定制解决方案,从益生菌菌株到增强食品和补充剂营养特性的营养酵母。致力于可持续性和质量,Gnosis创造的解决方案提供卓越的性能,并符合健康意识消费者的不断变化的需求。
我们提供的机会

  • 有机会代表一个专注于创新和可持续性的热情组织
  • 竞争性的薪酬和全面的福利,从第一天起就生效,包括健康、牙科、视力保险以及雇主匹配的401(k)
  • 11天带薪假期
  • 能够发挥你的专业技能,对业务和我们的可持续发展计划产生实际而有意义的影响
  • 持续成长和发展机会,包括国际范围,能够成长为一名人员经理,并在加拿大和拉美等地区获得专业知识

你将如何为我们的成功做出贡献
你不仅仅是遵守法规——你将重新定义可能性。作为我们的监管事务经理,你将成为我们美洲增长的战略引擎,将合规性转化为竞争优势。你在DSHEA、FDA和FTC要求方面的专业知识将打开新市场,指导产品在北美市场的注册和合规性,确保所有相关法规得到满足。你将与跨职能团队合作,推动产品从概念到市场的全过程,同时与全球监管机构保持沟通,确保我们的产品在全球范围内符合标准。你还将参与制定长期的监管战略,帮助公司在快速变化的法规环境中保持领先地位。

查看英文原文

Elevate the future with 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 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
  • 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
  • Health claim support
  • 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
  • Coordinate appropriate contacts for customer questions
  • 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.
Originally posted on Himalayas

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