Senior Regulatory Affairs Manager- Nutraceuticals
We're working with the nutraceutical division of a growing health and wellness company based in Bergen County, New Jersey. A commutable distance of 30 minutes from NYC or 45 minutes from Newark, this organization is searching for a Senior Regulatory Affairs Manager within the nutraceutical manufacturing space.
Our client offers end-to-end support across formulation, production, quality assurance, packaging, labeling, and distribution. Leveraging a global network of scientific talent and strategically located facilities across North America and Asia, the organization has access to leading technologies, premium ingredients, and evolving industry trends, positioning it for continued growth within the nutraceutical market.
Key Responsibilities
Regulatory Compliance & Strategy
• Lead regulatory activities to ensure compliance with U.S. and international regulations governing food, nutraceutical, and speciality ingredient products.
• Monitor regulatory developments and provide guidance on compliance requirements, product claims, and market access strategies.
• Partner with cross-functional teams to support product development and commercialization initiatives.
Documentation & Regulatory Support
• Oversee the preparation and maintenance of regulatory and technical documentation, including ingredient disclosures, compliance certifications, technical specifications, and labeling support.
• Ensure documentation and product claims meet applicable regulatory standards.
• Support regulatory submissions, certifications, and approvals for products and ingredients across global markets.
• Serve as a key regulatory resource for internal stakeholders, customers, and external partners.
Labeling & Regulatory Support
• Provide regulatory guidance on ingredient labeling, product claims, and compliance with applicable U.S. and international regulations.
• Support customer inquiries by reviewing and supplying regulatory documentation, certifications, and compliance information.
• Partner with commercial and marketing teams to ensure product communications and claims align with regulatory requirements.
• Evaluate technical and scientific documentation to help substantiate product performance, efficacy, and health-related claims.
Qualifications & Experience
• Bachelor's degree in Regulatory Affairs, Nutrition, Food Science, Chemistry, or a related discipline; advanced degree preferred.
• Prior experience within the food ingredients, functional ingredients, nutraceutical, or dietary supplement industries is highly desirable.
• Strong working knowledge of FDA regulations, including CFR Title 21 (Parts 101, 111, and 117), the FD&C Act, DSHEA, FSMA, FPLA, and GRAS requirements.
• Proven experience supporting regulatory compliance programs, maintaining regulatory documentation, and responding to customer and stakeholder inquiries.
• Comprehensive understanding of domestic and international regulatory requirements governing ingredient products.
• Strong organizational, project management, and cross-functional collaboration capabilities.
• Demonstrated ability to lead teams, influence stakeholders, and drive regulatory initiatives in a fast-paced environment.
• Excellent communication skills, with the ability to clearly convey complex regulatory concepts to both technical and non-technical audiences.
Only candidates with an authorized right to work in the United States will be considered. This position is not applicable for visa sponsorship.
Our client offers end-to-end support across formulation, production, quality assurance, packaging, labeling, and distribution. Leveraging a global network of scientific talent and strategically located facilities across North America and Asia, the organization has access to leading technologies, premium ingredients, and evolving industry trends, positioning it for continued growth within the nutraceutical market.
Key Responsibilities
Regulatory Compliance & Strategy
• Lead regulatory activities to ensure compliance with U.S. and international regulations governing food, nutraceutical, and speciality ingredient products.
• Monitor regulatory developments and provide guidance on compliance requirements, product claims, and market access strategies.
• Partner with cross-functional teams to support product development and commercialization initiatives.
Documentation & Regulatory Support
• Oversee the preparation and maintenance of regulatory and technical documentation, including ingredient disclosures, compliance certifications, technical specifications, and labeling support.
• Ensure documentation and product claims meet applicable regulatory standards.
• Support regulatory submissions, certifications, and approvals for products and ingredients across global markets.
• Serve as a key regulatory resource for internal stakeholders, customers, and external partners.
Labeling & Regulatory Support
• Provide regulatory guidance on ingredient labeling, product claims, and compliance with applicable U.S. and international regulations.
• Support customer inquiries by reviewing and supplying regulatory documentation, certifications, and compliance information.
• Partner with commercial and marketing teams to ensure product communications and claims align with regulatory requirements.
• Evaluate technical and scientific documentation to help substantiate product performance, efficacy, and health-related claims.
Qualifications & Experience
• Bachelor's degree in Regulatory Affairs, Nutrition, Food Science, Chemistry, or a related discipline; advanced degree preferred.
• Prior experience within the food ingredients, functional ingredients, nutraceutical, or dietary supplement industries is highly desirable.
• Strong working knowledge of FDA regulations, including CFR Title 21 (Parts 101, 111, and 117), the FD&C Act, DSHEA, FSMA, FPLA, and GRAS requirements.
• Proven experience supporting regulatory compliance programs, maintaining regulatory documentation, and responding to customer and stakeholder inquiries.
• Comprehensive understanding of domestic and international regulatory requirements governing ingredient products.
• Strong organizational, project management, and cross-functional collaboration capabilities.
• Demonstrated ability to lead teams, influence stakeholders, and drive regulatory initiatives in a fast-paced environment.
• Excellent communication skills, with the ability to clearly convey complex regulatory concepts to both technical and non-technical audiences.
Only candidates with an authorized right to work in the United States will be considered. This position is not applicable for visa sponsorship.