Job Description

A Scientific & Regulatory Affairs Manager with expertise of navigating global markets for dietary supplements and ingredients is needed for a remote position based out of Austin, TX. In this critical role, the Scientific & Regulatory Affairs Manager will ensure that products meet regulatory standards and scientific requirements across global markets. They will provide strategic guidance in product composition, labeling, claims substantiation, ingredient qualification, and compliance with international regulations, driving innovation and supporting market expansion.

Scientific & Regulatory Affairs Manager Responsibilities:

Regulatory & Compliance Leadership:

• Ensure compliance with applicable international regulations, as well as domestic guidelines, regarding product composition, labeling, advertising, and overall communications.
• Collaborate with cross-functional teams to review and verify health claims, structure/function claims, and ingredient qualifications (e.g., GRAS, NDI) for multiple markets.
• Provide expert regulatory interpretation and guidance to support quality and safety across global supply chains.

Scientific Strategy & Innovation:

• Support product development initiatives by integrating scientific and regulatory insights to foster new product ideas and optimize existing formulations for international markets.
• Oversee the development and review of technical documentation, including specifications, protocols, master manufacturing records, and regulatory submissions, ensuring they meet both scientific standards and regulatory requirements.

International Market Expertise & Advocacy:

• Monitor emerging global trends, regulatory changes, and consumer demands in key international markets.
• Develop and implement regulatory strategies that support product innovation and market expansion internationally, including proactive engagement with industry groups and regulatory bodies worldwide.
• Serve as a subject matter expert at industry conferences and advisory committees, advocating for favorable regulatory environments and leveraging scientific data to support business growth.

Cross-Functional Collaboration & Leadership:

• Lead cross-functional teams including R&D, marketing, and quality assurance to ensure streamlined product development and regulatory compliance.
• Mentor and develop team members in regulatory best practices, fostering a culture of continuous improvement and compliance across international jurisdictions.

Scientific & Regulatory Affairs Manager Requirements:

• Minimum 5+ years of experience in regulatory affairs and scientific roles within the dietary supplements, nutraceuticals, or ingredients industry, with a strong focus on international markets.**
• Bachelor’s degree in Life Science, Nutrition, Chemistry, or a related field; an advanced degree (Master’s, PhD, RD) is preferred.
• Deep understanding of both US and international regulatory frameworks (e.g., DSHEA, EU Novel Foods, etc.) as they relate to dietary supplements and nutraceuticals.
• Proven track record in product composition, labeling, claims substantiation, and ingredient qualification (e.g., GRAS, NDI) on a global scale.
• Exceptional written and verbal communication skills, with the ability to effectively disseminate complex regulatory and scientific information internally and externally.
• Strong project management and analytical skills, with experience in managing multi-market regulatory strategies and cross-border product compliance.
• Experience collaborating with regulatory bodies, industry groups, and scientific societies is highly desirable.
• Willingness to travel occasionally for international meetings and industry events.

**Candidates without industry experience or international markets expertise will not be considered.**

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