Sr Manager Regulatory and Scientific Affairs (Remote)
NestléAbout the role
At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life®, Nature's Bounty®, Vital Proteins®, Orgain®, Nuun®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.
At Nestlé Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.
Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.
Position Summary:
The Regulatory & Scientific Affairs Senior Manager is responsible for assuring that Nestlé Health Science (NHSc) products fully comply with applicable US regulations and internal Nestlé policies. This function is responsible for but not limited to regulatory compliance as pertains to ingredient and product composition, labeling, product claims, and associated communications. This position is expected to master the regulatory environment for the products commercialized by NHSc in the US for which the Senior Manager is responsible, with may include dietary supplements, conventional foods, and medical foods. This position is expected to display Nestlé leadership attributes and is responsible for managing a professional regulatory team and guiding cross-functional stakeholders in areas like recipe compliance, labeling, claims substantiation, ingredient qualification (e.g. GRAS, NDI), and nutrition science. The Regulatory & Scientific Affairs Senior Manager also develops and implements regulatory strategies to support innovation projects and works in anticipation of regulatory developments with the potential to affect the current portfolio and future pipelines. Finally, the Senior Manager is expected to professionally represent NHSc within the larger Nestlé environment, as well as externally through participation in industry, trade, and advocacy activities in support of NHSc priorities.
Key Responsibilities:
Regulatory Compliance:
• Ensure full regulatory compliance with applicable US regulations and internal Nestlé policies in terms of ingredient and product composition, labeling, advertising, website, social media, educational content, and all associated communications.
• Perform the regulatory qualification of raw materials/ingredients (e.g. GRAS, NDI) and finished product recipe validations in support of new and renovated products.
• Work proactively with commercial partners and functional departments to develop, review, and analyze the regulatory compliance, scientific accuracy, and adequate substantiation of product claims, including but not limited to nutrient content claims, health claims, and structure/function claims.
• Clearly communicate to the business any area of regulatory risk or opportunity and ensure that regulatory strategies are developed and effectively implemented.
• Provide regulatory interpretation and guidance to cross functional teams, including new and emerging laws and regulations, pertaining to product manufacturing, labeling, packaging, claims, or other regulatory matters.
• Advise on regulatory aspects of factory controls and testing as well as product variances and compliance criteria.
Innovation and Renovation:
• Partner and collaborate cross-functionally with Marketing, Innovation, and R&D/Product Development to proactively identify and create opportunities for innovative product claims, positioning, and support the development of the business strategy.
• Provide scientific and regulatory expertise to drive Innovation & Renovation (I&R) concepts, ensuring the implementation of a regulatory strategy to support new product development.
• Conduct regulatory review of projects at each stage gate as deemed necessary to ensure compliance and successful progression.
Regulatory Environment:
• Participate in setting an
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