Lesaffre North America

Regulatory Affairs Manager

Lesaffre North America

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

SeniorLead

About the role

  • 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

Requirements

  • 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
Benefits
  • 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 the ability to take on new challenges and collaborate across our international business units

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory affairsU.S. dietary supplement regulationStructure/Function ClaimsSupplement Facts labelingregulatory complianceregulatory impact assessmentregulatory guidancemarket accesscompetitor analysisregulatory watch
Soft skills
communicationcollaborationadvising senior leadershipcross-functional teamworkrelationship buildinganalytical thinkingproblem-solvingknowledge sharingcustomer engagementadaptability
Certifications
Bachelor’s degree in Life SciencesBachelor’s degree in Regulatory Affairs