Regulatory Affairs Sr. Manager

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Laboratory & Life SciencesRegulatory Affairs Associate

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Overview

About Niagen Bioscience Niagen Bioscience (NASDAQ:NAGE), formerly ChromaDex, Inc., is a global bioscience company uncovering the potential of NAD+ with precision science.

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Laboratory & Life SciencesRegulatory Affairs Associate

About Niagen Bioscience

Niagen Bioscience (NASDAQ:NAGE), formerly ChromaDex, Inc., is a global bioscience company uncovering the potential of NAD+ with precision science. Backed by 25 years of research and innovation, our team discovers, develops, and creates solutions to help people Age Better®. 

Our flagship ingredient, Niagen®, is one of the world's most extensively researched NAD+ precursors, backed by 35+ published, peer-reviewed human clinical studies and 300+ global research partnerships with leading institutions. Our brands are Tru Niagen®, a daily supplement proven to increase NAD+ levels, and Niagen® Plus, offering pharmaceutical-grade IV and injectable therapies.

As pioneers in NAD+ technology, Niagen Bioscience sets the gold standard in scientific rigor. We operate from three strategic locations in California and Colorado, positioning us at the forefront of the rapidly growing healthy-aging industry.

Our C.H.E.(pronounced chi)

We enjoy working with like-minded people who embody “C.H.E.” and share our passion for health, wellness, discovery, and innovation. In our collaborative environment, employees quickly adapt to different situations, bringing:

Character – A positive attitude, commitment to success, and strong ethics.

Horsepower – Good judgment, creative problem-solving, and a strong work ethic.

Experience – Functional knowledge and skills to perform efficiently.

If you're eager to work with incredible people and contribute to something meaningful, join our team and help shape the future of bioscience on a global scale!

What we Offer:

A competitive salary, affordable health benefits, company sponsored life insurance, wellness initiatives, retirement savings with company match, paid time off, career growth opportunities and a flexible/hybrid work environment.

As a Regulatory Affairs Senior Manager, you will assume a key function as part of the Regulatory Affairs (RA) group. This role will work in a cross-functional environment to manage obtaining and maintaining ingredient authorizations and product registrations necessary to commercialize products globally, with a primary focus on Asia. Additionally, this role will be responsible for driving the development and optimization of internal process efficiencies, reviewing product claims for compliance, critical review and evaluation of new and existing ingredient status and acceptability, regulatory review of marketing materials, and assisting in the management of projects essential for the long-term success of commercially available products in the Niagen Bioscience portfolio. This position is expected to participate in relevant external initiatives pertaining to the Niagen Bioscience business to advance the science and brand of products.

Drive and manage the dietary supplement (health food) ingredient and/or final product registrations in Asia, with a specific focus on East Asian and Southeast Asian countries.

Manage the renewals of ongoing license or registration needs.

Conduct regulatory assessment of formulas, supporting documentation, and labels to determine overall acceptability and compliance with country-specific requirements .

Recommend options and proactive solutions to assure regulatory compliance of Niagen Bioscience ingredients and products and to drive business.

Develop market-specific substantiation guidelines for claims and review marketing materials to ensure appropriate and regulatory-compliant messaging.

New product development and formulation support for the Asian markets, including raw material, claim, and label acceptability.

Develop and maintain relationships with external partners, including regulatory agencies and trade associations, staying up to date on ever-changing global regulations and representing Niagen Bioscience, as required.

Positively add to the culture of the organization and participate across the broad spectrum of activity the function is responsible for to deliver on the total organizational goals.

May be required to travel domestically up to 25% of the time. Possible international travel may be required, on a limited basis.

Minimum BA or BS in Nutrition, Chemistry, or another related field.

6+ years of experience in regulatory within the dietary supplement/health food sector.

Familiarity of the dietary supplement/health food regulatory framework and requirements in East Asian and Southeast Asian markets. Previous experience with Blue Hat in China and/or importation regulations in Asia a plus.

Strong experience as a regulatory lead in core teams for sustaining and development projects.

Understanding of global evolving packaging and chemical regulations (Extended Producer Responsibility or PFAS) is a plus.

Excellent oral and written communication skills in English. Ability to analyze complex technical data and regulations and effectively communicate the information to cross-functional teams.

Proficiency in Mandarin or Cantonese a plus.

Ability to work independently and as a member of a project team, manage a high volume of work, prioritize effectively, meet numerous deadlines in a fast-paced setting with evolving goals and objectives. Self-motivated, organized, and able to multi-task.