Regulatory Affairs Manager

This is a fully remote position, open to applicants in Illinois, +1 more state.

📋 Description

• Exhibit a steadfast dedication to Lesaffre's safety-first culture by adhering to all safety protocols and engaging in mandatory safety programs.

• Propel expansion initiatives in Canada leveraging existing ingredient dossiers.

• Lead global regulatory projects within the Americas.

• Collaborate with international teams to enhance data utilization and simplify market access.

• Assess customer business landscapes and competitor strategies to formulate US-compliant structure/function claims.

• Investigate health claim prospects in Canada using data developed by experts.

• Execute regional regulatory frameworks while ensuring alignment with global standards.

• Provide on-the-ground regulatory support to customers and commercial teams in the US and Canada.

• Advise on labeling and compliance in accordance with global and regional regulations.

• Direct the regulatory function in customer projects.

• Participate in meetings with customers and key accounts.

• Develop regulatory guidance documents (Q&As, country guides, training materials).

• Contribute to meetings focused on global regulatory affairs and the Americas regional leadership team.

• Oversee and mentor the Scientific Technical Coordinator-LATAM on regulatory and scientific issues.

• Mitigate regulatory risks through collaboration with the LATAM coordinator.

• Keep track of the regulatory landscape in the US and Canada.

• Conduct regulatory monitoring for the Americas and share insights globally.

• Generate competitive insights through analysis and customer interactions.

• Collaborate with commercial/marketing teams on regulatory strategies.

• Convey market intelligence to global RA & IP teams.

• Engage in evaluating the impact of control changes.

• Ensure regulatory precision in customer-facing materials.

• Facilitate regional compliance assessments and documentation.

• Act as the company representative in professional associations in the US and Canada.

• Establish connections with local lawyers/consultants to enhance knowledge of regulatory affairs.

• Coordinate suitable contacts for customer inquiries.

• Perform other assigned duties.

⛳️ Requirements

• Bachelor's degree in life sciences, regulatory affairs, or a related discipline.

• 7–10 years of experience in regulatory affairs within nutraceuticals, dietary supplements, or consumer health.

• Extensive knowledge of U.S. dietary supplement regulations as outlined in the Dietary Supplement Health and Education Act (DSHEA).

• Proven ability to navigate the requirements set forth by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

• Practical experience with structure/function claims, supplement facts labeling, and associated compliance frameworks.

• Comprehensive understanding of how a premium ingredient supplier aids customer partners in regulatory compliance without holding direct responsibility for finished product labels.

• Demonstrated success in advising senior leadership and cross-functional teams on regulatory issues.

• Proven experience in managing claims development, submissions, and compliance across various markets.

• Strong ability to interpret and convey scientific/regulatory information for commercial use.

• Must reside in the United States, preferably in the New York City or Chicago metropolitan areas, and be capable of working cross-functionally across time zones.

• Willingness to travel 30-40% of the time across the Americas, with occasional global travel to Europe.

🏝️ Benefits

• Competitive salary and comprehensive benefits package commencing on the first day, including health, dental, vision, and a 401(k) plan with employer matching.

• 11 paid holidays.

• Opportunities for ongoing growth and development, including international exposure, the chance to advance as a people manager, and gain expertise in regions such as Canada and LATAM.