Lesaffre

Regulatory Affairs Manager

Lesaffre

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

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 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.

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 affairsdietary supplement regulationStructure/Function ClaimsSupplement Facts labelingregulatory complianceregulatory impact assessmentregulatory intelligenceclaims developmentsubmissionsscientific communication
Soft skills
advising senior leadershipcross-functional collaborationcommunicationanalytical thinkingproblem-solvingcustomer engagementnetwork developmentknowledge sharingteam leadershipinsight development