Regulatory Affairs Manager, Americas

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

How Youll Contribute to Our Success

The Regulatory Affairs Manager Americas will be a strategic and collaborative partner embedded within the regional leadership team to drive growth and innovation. They will leverage deep regulatory expertise to provide guidance that enables speed to market while ensuring compliance with global standards. By working closely with cross-functional leaders across Sales Marketing Operations Quality Medical Affairs and R&D the Regulatory Affairs Manager will help the Americas region achieve its objectives. Additionally they will represent the companys interests in external industry forums such as the Council for Responsible Nutrition bringing regulatory and scientific insights to shape the dialogue. This role is crucial in ensuring the Americas regions success by navigating the complex regulatory landscape mitigating risks and unlocking new opportunities for the business.

What Youll do as our Regulatory Affairs Manager Americas  

• 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 customers 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 customers 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 departments knowledge and capabilities.
  • Decide on the persons to be contacted in case of customer questions.
• Other duties as assigned.

Qualifications :

Required qualifications:  

• Bachelors degree in Life Sciences Regulatory Affairs or related field.
• 710 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.

Preferred qualifications: 

• Masters degree is a plus.
• Knowledge of Canadian and LATAM regulatory frameworks is preferred.
• Fluency in Spanish and/or Portuguese is a bonus.

Additional Information :

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.   

Remote Work :

Yes

Employment Type :

Full-time