Americas Regulatory Affairs Leader for Market Access

Gnosis by Lesaffre; United States; Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

401(k) with employer match

11 paid holidays

Résumé du poste

Gnosis by Lesaffre, a division of Lesaffre, seeks a Regulatory Affairs Manager, Americas to lead regulatory strategy for the US, Canada, and LATAM markets. You will partner with Sales, Marketing, Operations, Quality, Medical Affairs, and R&D to enable speed to market while ensuring global compliance.

Travel up to 40% across the Americas is expected. The role requires strong DSHEA knowledge, experience with claims, and cross-functional leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.
• 7–10 years of regulatory affairs experience in nutraceuticals, dietary supplements, or food ingredients.
• Strong expertise in U.S. dietary supplement regulation under DSHEA (FDA/FTC).
• Experience with Structure/Function Claims and labeling compliance.
• Ability to advise senior leadership and cross-functional teams.
• Willingness to travel 30–40% across the Americas; occasional global travel.
• English fluency required.
• Based in United States, preferably central or eastern time zones.

Responsabilités

• Develop Market Access: leverage existing dossiers to assess expansion opportunities and maximize regulatory data value in Canada.
• Support global regulatory projects for the Americas and coordinate with other regions.
• Provide regulatory guidance for US, Canada, and LATAM market requirements.
• Advise NORAM customers and commercial teams with on-the-ground regulatory support.
• Create regulatory guidance documents for NORAM team (Q&A, country guides, training).
• Participate in Global RA rhythm and Americas leadership cadence.
• Support LATAM regulatory matters with LATAM coordinator (70/30 split).
• Monitor regulatory risks and build NORAM regulatory watch.
• Collaborate with RA, Medical Affairs, Substantiation, Quality, and R&D teams.

Connaissances

Regulatory affairs

DSHEA knowledge

Claims development

FDA/FTC compliance

Cross-functional collaboration

Scientific communication

English fluency

Travel readiness

Formation

Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field

Description du poste

Gnosis by Lesaffre, a division of Lesaffre, seeks a Regulatory Affairs Manager, Americas to lead regulatory strategy for the US, Canada, and LATAM markets. You will partner with Sales, Marketing, Operations, Quality, Medical Affairs, and R&D to enable speed to market while ensuring global compliance.

Travel up to 40% across the Americas is expected. The role requires strong DSHEA knowledge, experience with claims, and cross-functional leadership.