Regulatory & Scientific Lead – US (Remote)

FuseGlobal; United States; Remote; USD 50,000 - 71,000; Full time

Benefits offered by this job

Up to $44/hour + OT

Medical insurance

Vision insurance

401(k)

Disability insurance

Job summary

FuseGlobal seeks a Regulatory & Scientific Specialist to ensure products fully comply with US regulations and internal policies across composition, labeling, and communications. You will lead regulatory strategy for dietary supplements and conventional foods and guide cross-functional teams on claims substantiation and ingredient qualification (GRAS, NDI).

Remote in the United States, you will collaborate with Medical Affairs, Marketing and Product Development to identify compliant opportunities

Qualifications

• 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.
• Operating within US regulatory frameworks and internal policies.

Responsibilities

• 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.
• Review and analyze substantiation of Health Claims, Structure/Function claims and ingredient qualification (e.g. GRAS, NDI).
• Communicate regulatory concerns to the business and develop effective regulatory strategies.
• 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: Collaborate with Medical Affairs, Marketing and Product Development to identify opportunities for innovative product claims and support development strategy.
• Provide regulatory review of projects at stage gates to ensure compliance and progression.

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Education

Bachelor’s degree in Regulatory Affairs, Life Science, Nutrition, Chemistry, or related

Advanced degree such as Masters or RD

Job description

FuseGlobal seeks a Regulatory & Scientific Specialist to ensure products fully comply with US regulations and internal policies across composition, labeling, and communications. You will lead regulatory strategy for dietary supplements and conventional foods and guide cross-functional teams on claims substantiation and ingredient qualification (GRAS, NDI).

Remote in the United States, you will collaborate with Medical Affairs, Marketing and Product Development to identify compliant opportunities