Nestle Sr. Manager, Regulatory Affairs in Bridgewater, New Jersey
Nestl 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.
Nestl Health Science , a wholly-owned subsidiary of the Nestl 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 Sr. Manager is responsible for assuring that Nestl Health Science products fully comply with applicable US regulations and internal Nestl policies on product composition, labels and associated communications. This position provides leadership to cross-functional teams in areas like claims substantiation, ingredient qualification (e.g. GRAS, NDI), and nutrition science to support the effective and aggressive competitiveness of the retail market. The Regulatory Sr. 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.
Assure products regulatory compliance with applicable US regulations and internal Nestl 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.
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 a plus.
8-10 years of experience in the food and 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.
Availability for national and international travel.
The Nestl Companies are equal employment and affirmative action employers and looking for diversity in qualified candidates for employment.
Category: Management, Food Safety, Nestle Health Science