Regulatory & Scientific Specialist

Fuseglobal; United States; À distance; USD 36 000 - 61 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Vision insurance

401(k)

Disability insurance

Résumé du poste

Fortune 100 Food & Beverage Manufacturing is seeking a Regulatory & Scientific Specialist to ensure products comply with US regulations and internal policies. Remote in the United States; 9-month initial term with potential extension.

The role leads recipe compliance, labeling refusals, claims substantiation and ingredient qualification (GRAS, NDI) across cross-functional teams. The position supports innovation projects with regulatory strategies and works with Marketing, Medical Affairs and

Qualifications

• Bachelor’s degree required or preferred in Regulatory Affairs, Life Science, Nutrition, Chemistry or related field.
• 5+ years of experience in food and/or dietary supplement regulatory environments with DSHEA knowledge.
• Ability to manage complex projects with pragmatic prioritization.

Responsabilités

• Ensure full regulatory compliance with US regulations and internal policies for product composition, labeling, advertising and communications.
• Review and analyze health claims, structure/function claims and ingredient qualification (GRAS, NDI).
• Provide regulatory interpretation and guidance to cross-functional teams.
• Advise on regulatory aspects of factory controls, testing, variances and compliance criteria.
• Collaborate with Medical Affairs, Marketing and Product Development to identify opportunities for innovative product claims and support business strategy.
• Provide regulatory review of I&R concepts and ensure regulatory strategy supports development and progression.

Connaissances

Regulatory compliance

Project management

Communication

Formation

Bachelor's degree in Regulatory Affairs or Life Sciences

Advanced degree (Masters or RD)

Description du poste

Title: Regulatory & Scientific Specialist
Location: Remote (candidates must be located in the United States)
Company: Fortune 100 Food & Beverage Manufacturing (FuseGlobal has worked with this company for 20 years)
Initial term:9 months (position expected to run longer)
Schedule: Mon-Friday 9 AM-5 PM or 8 AM-4 PM

About This Role:

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.

What You'll Do:

• Regulatory Compliance:
• 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.
• Innovation and Renovation:
• 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. Additionally, provide regulatory review of projects at each stage gate as deemed necessary to ensure compliance and successful progression.

What You Bring:

• Bachelor’s degree in Regulatory Affairs, Life Science, Nutrition, Chemistry, or a related discipline is preferred. Advanced degree such as Masters or RD, or similar, is a plus.
• 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.
• Up to $44.00 per hour + Overtime
• Medical insurance
• Vision insurance
• 401(k)
• Disability insurance