Regulatory & Scientific Affairs Specialist

Remote role

Job Description:

• Work schedule: Full-time, Monday – Friday, 9am – 5pm or 8am - 4pm
• Work location: Remote
• This role is responsible for assuring that Holistic Health 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 Holistic Health 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).
• The Regulatory Manager 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.      

Regulatory Compliance:

• Ensure full regulatory compliance with applicable US regulations and internal client 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.

Experience and Education Requirements:

• 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.

About us:
At our organization, we take our mission and values to heart! We are on a mission to offer more and better jobs all over the world! Our goal is to care for you while you care for our clients and get you paid the highest pay possible. All our associates working with us are expected to embrace our RACE values: R - Results Matter, A- Approachable, C - Care, and E - Emergency i.e. work with a sense of urgency.

For more relevant job opportunities please visit our website: Denken Solutions Careers