Manager, Regulatory Affairs - Vitaflo

2 days left

Piscataway, NJ, United States
Apr 19, 2017
Apr 29, 2017
Contract Type
Full Time

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.

Position Summary:

To ensure that Vitaflo-NHSc products fully comply with applicable US and Canadian regulations and internal Nestlé policies. This function is responsible for the construct, communication and implementation of regulatory strategies across current portfolio and Innovation and Renovation projects, making sure cross functional teams deliver safe, effective and compliant products. This function is expected to master the regulatory environment of medical foods/infant formulas, food for special dietary uses, and claims while working to address each market's unique regulatory context. The Regulatory manager will assist the Director of Regulatory Affairs in the engagement with government bodies, KOL, scientific societies and trade associations to discuss and protect NHSc interests. 

Primary Responsibilities:

Innovation and Renovation:
• Partner cross functionally with Marketing and Product development to help proactively identify and create opportunities for innovative product claims, product positioning and support development of the business strategy, at both US, Canada and Global levels.
• Contribute with scientific and regulatory expertise to qualify I&R concepts, and provide regulatory review of projects at each stage gate

• Ensure full regulatory compliance of all labels and labelling for all retail and institutional products, including advertising, website, and sales collateral, with particular attention to protecting medical food (US) and FSDU (Canada) designation and scientific claim substantiation
• Identify, assess and clearly communicate to the business any regulatory risks with recommendations for options for risk elimination or mitigation
• Provide regulatory interpretation and guidance cross functionally to the business; specifically to product design and marketing for appropriate product claims and consumer advertising and communications, as well as to Global teams about US and Canadian-specific regulatory environment
• Advise on product variances and compliance criteria.

Develop Talent
• As required, provide training, development, and coaching to specialists with the aim of building succession planning and strengthening regulatory team contributions

Regulatory Environment Management
• Assist Director to identify, develop, implement and lead strategies to improve effectiveness and efficiency of overall regulatory and scientific affairs environment in alignment with NHSc objectives
• Provide essential US and Canada input into Global regulatory functions, seeking to harmonize formulas and labels, whenever possible, to reduce inter-country barriers to trade

Education and Experience:

• Life Science University degree/Pharmacist/Chemist;
• Ph.D. highly preferred. MBA, RAC and other degrees/certifications are a plus;
• 5-10 years of experience in the health care industry with exposure to food products, especially dietary supplements, infant formulas and/or medical foods.
• Exposure to industry groups, government authorities (spec. FDA and Health Canada), and scientific societies;
• Clear and full expertise in Regulatory Affairs;
• International experience is a plus.

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