Regulatory & Scientific Specialist

FuseGlobal

3d•Remote

About The Position

This role is responsible for assuring that the company's products fully comply with applicable US regulations and internal policies. This function is responsible for but not limited to product composition, labels and associated communications. This position is expected to understand the regulatory environment of the products commercialized by the company in the US, including dietary supplements and conventional foods. This position provides leadership to cross-functional teams in areas like recipe compliance, labeling, claims substantiation, and ingredient qualification (e.g. GRAS, NDI). This person 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.

Requirements

5+ 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; labeling; Health Claims & Structure/Function Claims; overall product communications).
Ability to manage projects of high complexity and prioritize actions based on clear and pragmatic criteria.

Nice To Haves

Advanced degree such as Masters or RD, or similar, is a plus.

Responsibilities

Ensure full regulatory compliance with applicable US regulations and internal policies in terms of product composition, advertising, labeling, website, and all associated communications.
Work proactively with other departments to review and analyze the accuracy and substantiation of Health Claims, Structure/Function claims and the 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 to cross functional teams.
Advise on regulatory aspects of factory controls and testing as well as product variances and compliance criteria.
Partner and collaborate cross-functionally with Medical Affairs, Marketing and 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 qualify Innovation & Renovation (I&R) concepts, ensuring the implementation of a regulatory strategy to support new product development.
Provide regulatory review of projects at each stage gate as deemed necessary to ensure compliance and successful progression.