Regulatory Affairs Sr. Manager

About the Role:

 
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.   

Core Expectations: 

• 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.  

 

Qualifications and Success Factors:

• 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.  

 

Competencies & Skills 

• 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.   

• Highly attentive to detail. Analytical and strategic with the ability to provide creative solutions. 

• Competent use of MS Office programs, experience with Asana also helpful.