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About Nestlé health science

Created in 2011 by the world’s leading Nutrition, Health and Wellness Company, Nestlé Health Science is a unique health science company focused on advancing the role nutrition plays in changing the course of health for consumers, patients and healthcare professionals. Focused on delivering quality-of-life benefits through nutritional solutions, we harness scientific and clinical advances to improve health through managed nutrition. With approximately 3,000 employees around the world and a global presence in about 50 markets, we invite you to impact the future of health with us.

Regulatory Affairs Manager

Job Number 18007071 Company Nestle Health Science Location Bridgewater, New Jersey

Description

Nestlé Health Science (NHSc) is a company on a mission and on the move, motivated by the opportunity to forge a major therapeutic role for nutrition in the management of health and establish a new industry between food and pharmaceuticals. The two elements of the equation are simple; societies are ageing and age and lifestyle related diseases are spiraling. Needs are growing for safe, effective and cost-effective solutions. At the same time, scientific understanding of health, disease and the potential of nutrition – as an integral part of managing health and disease – is growing.

Nestlé Health Science, a wholly-owned subsidiary of the Nestlé Group, was created in 2011 to be a leader in these developments and make things happen. We have over 3,000 employees around the world with a wide mix of capabilities – from bio-medical engineers to regulatory specialists, medical delegates (sales force) and health economic experts that reflect our dynamism and intent to create.

The Regulatory Manager is responsible for assuring that Nestlé Health Science products fully comply with applicable US regulations and internal Nestlé policies on product composition, labels and associated communications. This position is expected to master the regulatory environment of the products commercialized by NHSc in the US, including medical foods, exempt infant formulas and food for special dietary uses. This position provides leadership to cross-functional teams in areas like recipe compliance, labeling, claims substantiation, ingredient qualification (e.g. GRAS, NDI), and nutrition science. The Regulatory Manager also develops and implements regulatory strategies to support innovation projects and works in anticipation of regulatory developments with potential to affect the current portfolio and future pipelines.

KEY RESPONSIBILITIES
• Compliance:
• Assure products’ full regulatory compliance with applicable US regulations and internal Nestlé policies in terms of product composition, labels and associated communications.
• Work proactively with other departments to review and analyse accuracy and substantiation of Health & Structure/Function claims and qualification of ingredients (e.g. GRAS, NDI).
• Clearly communicate to the business any area of regulatory concern and assure that regulatory strategies are developed and effectively implemented.
• Provide regulatory interpretation and guidance cross functionally to US-based and Global teams.
• Advise on regulatory aspects of factory controls and testing as well as product variances and compliance criteria.
• Innovation and Renovation:
• Collaborate cross functionally to support the identification and creation of opportunities for innovative product claims and positioning in support of the business strategy (both US and Global teams).
• Provide scientific and regulatory expertise to qualify I&R concepts and ensure that the most feasible regulatory strategy is implemented in support of innovation projects.
• Regulatory Environment Management
• In alignment with company objectives, participate in setting and executing advocacy strategies.
• Clearly convey the US regulatory perspective for consideration by global teams and other Nestle group companies.
• Monitor and evaluate consumer trends and the regulatory landscape to anticipate regulatory developments.
• Support development of strategies to improve effectiveness and efficiency of overall regulatory and scientific affairs environment.
• Foundation:
• Support efforts to foster regulatory knowledge throughout the organization.
• Provide training, development, and coaching to regulatory team with the aim of building capacity and strengthening regulatory team contributions.

Qualifications

EXPERIENCE AND EDUCATION REQUIREMENTS
• Bachelor’s degree in Food Science, Nutrition, Chemistry, or related discipline.
• MSc or Ph.D. highly preferred. MBA and other degrees are a plus.
• 5-10 years of experience in the food and/or dietary supplements’ regulatory environment with full expertise on regulatory compliance (i.e. product composition; DSHEA; ingredient qualification e.g. GRAS, NDI; label, Health & Structure/Function Claims, overall product communication, etc).
• Exposure to industry groups, government authorities (e.g. FDA), and other scientific societies.
• Ability to manage projects of high-complexity and prioritize actions based on clear and pragmatic criteria.

The Nestlé Companies are equal employment and affirmative action employers and looking for diversity in qualified candidates for employment.

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