Sr. Specialist, Global Regulatory Affairs
Remote
Join our TRU Crew!
About ChromaDexChromaDex Corp. (NASDAQ:CDXC) is a global bioscience company dedicated to healthy aging. Our scientists’ partner with leading universities and research institutions worldwide to discover, develop, and create solutions to positively impact human health. Our flagship ingredient, NIAGEN® nicotinamide riboside, is backed by clinical and scientific research. Our consumer product is TRU NIAGEN® which safely and effectively increases NAD levels, a vital cellular resource, that supports healthy living and improving the way we age. We need smart, collaborative people to help us build the next frontier bioscience company dedicated to enabling wellness and well-being for every demographic.At ChromaDex, we are committed to scientific excellence, collaboration, and innovation. Our culture fosters creativity, integrity, and a shared passion for improving lives. We seek talented professionals who are eager to contribute to a company that prioritizes cutting-edge research, real-world impact, and a dynamic work environment.
Position SummaryAs a Senior Specialist, Global Regulatory Affairs, you will assume a key function as part of the Scientific & Regulatory Affairs (SRA) group. This role will work in a cross-functional environment to support obtaining and maintaining ingredient authorizations and product registrations/notifications necessary to commercialize products in the US and various international markets. Additionally, this role will be responsible for driving the development and optimization of internal process efficiencies, reviewing product claims for compliance, the 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 ChromaDex portfolio. This position is expected to participate in relevant external initiatives pertaining to the ChromaDex business to advance the science and brand of ChromaDex products. Job Duties & Responsibilities: · Review formulas, supporting documentation, and labels to determine overall acceptability and compliance with country-specific requirements and internal ChromaDex standards. This includes the assessment of ingredients, product claims, and other formula specifications (i.e. contaminants, allergens). Identify potential compliance risks. · Review of marketing materials to ensure appropriate and regulatory-compliant messaging; collaborate with different departments and external partners to review and revise as necessary (i.e. label copy, web content, marketing collateral etc.).· Drive development of internal processes that help improve the efficiency of the function, including request fulfillment, file storage, and document tracking. · Work cross-functionally, with external partners, and consultants to stay up to date on ever-changing global regulations. · Direct or manage coordination and preparation of necessary document packages to establish regulatory acceptability for ingredients and products in global markets. Recommend options and proactive solutions to assure regulatory compliance of ChromaDex ingredients and products and to drive business.· Manage the renewal of any ongoing license or registration needs. · Assist in the development and/or management of internal post-market surveillance and packaging regulation programs.· Represent ChromaDex as needed in external partner engagement, including trade associations and professional societies.· Collaborate with Scientific Affairs to assist with the maintenance of claim substantiation files and documentation.· May be required to travel domestically 10% of the time. Candidate Qualifications· Bachelor’s degree in nutrition, Chemistry, Regulatory Science, or a related field.· 2-5 years of experience in regulatory affairs, preferably in dietary supplements, cosmetics, or related industries.· Strong understanding of U.S., EU, Canadian, Australian, and Chinese regulatory frameworks.· Experience leading regulatory initiatives in product development and commercialization.· Familiarity with pharmacovigilance programs, global packaging regulations (e.g., Extended Producer Responsibility, PFAS), and chemical compliance is a plus.· Proactive and solution oriented. Candidate Competencies & Skills· 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.· Ability to work independently and as a member of a project team, manage a high volume of work, prioritize effectively, meet numerous deadlines. Self-motivated, organized, and able to multi-task. · Interest in working in a fast-paced setting with evolving goals and objectives. Ability to work consistently with a strong sense of urgency. · Highly attentive to detail. Analytical and strategic.· Ability to think critically, analyze problems and provide creative solutions.· Proactive and solution oriented.· Proficient in Microsoft Office Suite and 365 Compensation & BenefitsWe offer a competitive salary wage range of $85k - $105kfor this role based on experience, qualifications, and skills. In addition, this position offers a comprehensive benefits package, including:ü Health & Wellness: Medical, dental, and vision insuranceü Financial Security: 401(k) retirement plan with company matchü Work-Life Balance: Flexible Time Off (FTO) and company-paid holidaysü Career Growth: Professional development opportunitiesü Flexibility: Hybrid work model for enhanced work-life balance Commitment to a Diverse WorkplaceChromaDex is an equal opportunity employer dedicated to fostering an inclusive, diverse, and respectful workplace where People Matter. We are committed to providing equal employment opportunities to all individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or any other characteristic protected by law. We believe in promoting fairness, dignity, and respect for all, ensuring that every individual has an equitable opportunity to succeed and contribute to our mission. Apply
About ChromaDexChromaDex Corp. (NASDAQ:CDXC) is a global bioscience company dedicated to healthy aging. Our scientists’ partner with leading universities and research institutions worldwide to discover, develop, and create solutions to positively impact human health. Our flagship ingredient, NIAGEN® nicotinamide riboside, is backed by clinical and scientific research. Our consumer product is TRU NIAGEN® which safely and effectively increases NAD levels, a vital cellular resource, that supports healthy living and improving the way we age. We need smart, collaborative people to help us build the next frontier bioscience company dedicated to enabling wellness and well-being for every demographic.At ChromaDex, we are committed to scientific excellence, collaboration, and innovation. Our culture fosters creativity, integrity, and a shared passion for improving lives. We seek talented professionals who are eager to contribute to a company that prioritizes cutting-edge research, real-world impact, and a dynamic work environment.
Position SummaryAs a Senior Specialist, Global Regulatory Affairs, you will assume a key function as part of the Scientific & Regulatory Affairs (SRA) group. This role will work in a cross-functional environment to support obtaining and maintaining ingredient authorizations and product registrations/notifications necessary to commercialize products in the US and various international markets. Additionally, this role will be responsible for driving the development and optimization of internal process efficiencies, reviewing product claims for compliance, the 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 ChromaDex portfolio. This position is expected to participate in relevant external initiatives pertaining to the ChromaDex business to advance the science and brand of ChromaDex products. Job Duties & Responsibilities: · Review formulas, supporting documentation, and labels to determine overall acceptability and compliance with country-specific requirements and internal ChromaDex standards. This includes the assessment of ingredients, product claims, and other formula specifications (i.e. contaminants, allergens). Identify potential compliance risks. · Review of marketing materials to ensure appropriate and regulatory-compliant messaging; collaborate with different departments and external partners to review and revise as necessary (i.e. label copy, web content, marketing collateral etc.).· Drive development of internal processes that help improve the efficiency of the function, including request fulfillment, file storage, and document tracking. · Work cross-functionally, with external partners, and consultants to stay up to date on ever-changing global regulations. · Direct or manage coordination and preparation of necessary document packages to establish regulatory acceptability for ingredients and products in global markets. Recommend options and proactive solutions to assure regulatory compliance of ChromaDex ingredients and products and to drive business.· Manage the renewal of any ongoing license or registration needs. · Assist in the development and/or management of internal post-market surveillance and packaging regulation programs.· Represent ChromaDex as needed in external partner engagement, including trade associations and professional societies.· Collaborate with Scientific Affairs to assist with the maintenance of claim substantiation files and documentation.· May be required to travel domestically 10% of the time. Candidate Qualifications· Bachelor’s degree in nutrition, Chemistry, Regulatory Science, or a related field.· 2-5 years of experience in regulatory affairs, preferably in dietary supplements, cosmetics, or related industries.· Strong understanding of U.S., EU, Canadian, Australian, and Chinese regulatory frameworks.· Experience leading regulatory initiatives in product development and commercialization.· Familiarity with pharmacovigilance programs, global packaging regulations (e.g., Extended Producer Responsibility, PFAS), and chemical compliance is a plus.· Proactive and solution oriented. Candidate Competencies & Skills· 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.· Ability to work independently and as a member of a project team, manage a high volume of work, prioritize effectively, meet numerous deadlines. Self-motivated, organized, and able to multi-task. · Interest in working in a fast-paced setting with evolving goals and objectives. Ability to work consistently with a strong sense of urgency. · Highly attentive to detail. Analytical and strategic.· Ability to think critically, analyze problems and provide creative solutions.· Proactive and solution oriented.· Proficient in Microsoft Office Suite and 365 Compensation & BenefitsWe offer a competitive salary wage range of $85k - $105kfor this role based on experience, qualifications, and skills. In addition, this position offers a comprehensive benefits package, including:ü Health & Wellness: Medical, dental, and vision insuranceü Financial Security: 401(k) retirement plan with company matchü Work-Life Balance: Flexible Time Off (FTO) and company-paid holidaysü Career Growth: Professional development opportunitiesü Flexibility: Hybrid work model for enhanced work-life balance Commitment to a Diverse WorkplaceChromaDex is an equal opportunity employer dedicated to fostering an inclusive, diverse, and respectful workplace where People Matter. We are committed to providing equal employment opportunities to all individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or any other characteristic protected by law. We believe in promoting fairness, dignity, and respect for all, ensuring that every individual has an equitable opportunity to succeed and contribute to our mission. Apply
Job Profile
Benefits/PerksCollaborative culture Focus on wellness Remote work
Tasks- Assist in post-market surveillance
- Collaborate with departments
- Develop internal processes
- Ensure compliance
- Manage document packages
- Review formulas and labels
Compliance Cross-functional Collaboration Document management Ingredient Assessment Marketing review Process Optimization Project Management Regulatory Affairs
Experience5 years
Education
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