Lief Labs
Quality Regulatory Affairs Specialist (On-site)
Lief Labs, Santa Clarita, California, United States, 91382
Quality Regulatory Affairs Specialist (On-site)
Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house product development and R&D team creates the best-tasting and cutting-edge supplement formulations. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for many supplement categories. The
Quality Regulatory Affairs Specialist
will be a key contributor to ensuring full compliance with regulatory standards while upholding the highest levels of product quality. You will collaborate closely with cross-functional teams to ensure adherence to current Good Manufacturing Practices (cGMP) and all applicable regulatory requirements. Summary
The ideal candidate is well-versed in 21 CFR Part 111, USDA, FTC, and other regulatory standards as needed. Success in this position requires strong attention to detail, excellent communication skills, and a solid understanding of regulatory affairs within the nutraceutical and dietary supplement industry. Responsibilities
Review and approve raw material, packaging material, and finished product specifications, supplement facts panels, and labeling to ensure compliance with applicable regulations. Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle, from development to commercialization. Collaborate with R&D and Quality teams to assess formulations and claims for regulatory compliance. Maintain and update regulatory documentation, including formulation sheets, product registrations, and master files. Review/Approval of Master Manufacturing Record/Master Batch Record Shelf-life / Stability Data Oversight Claims Substantiation Risk Register / Label Approval Workflow Regulatory Requests Respond to client inquiries regarding formulas, including questions on claim substantiation, GRAS status, NDI compliance, and related regulatory matters. Review supplier-provided raw material and packaging material documentation. Collaborate cross-functionally with Procurement and R&D to qualify suppliers by reviewing and validating onboarding documentation. Collaborate with Lief’s Organic Certifier to ensure full compliance with the USDA National Organic Program. Collaborate with Lief’s Halal and Kosher Certifiers to ensure full compliance with their standards. Support customers in obtaining or maintaining certifications such as NSF, USP, Non-GMO Project Verified, USDA Organic, Kosher, Halal, Gluten-Free, Informed Sport, or Prop 65 compliance. Monitor changes in regulations and guidance documents issued by regulatory authorities and communicate updates to relevant stakeholders. Participate in continuous improvement initiatives to enhance regulatory processes and ensure alignment with industry best practices. Provide training and support to employees on document control procedures, system usage, cGMP and employee hygiene on an annual basis. Educate internal teams (QA, R&D, marketing) on current regulatory requirements. Act as the point of contact with certification bodies and auditors during application, renewal, or surveillance processes. Manage and maintain facility licenses and certifications, ensuring compliance with local, state, and federal regulatory requirements. Minimum Qualifications
Education/Knowledge : Education: Bachelor's degree in a relevant scientific discipline (e.g., chemistry, biology, pharmacy) required; advanced degree preferred. Minimum of 3 years of experience in regulatory affairs within the dietary supplement, pharmaceutical, food and beverage or related industry. Thorough understanding of FDA regulations (21 CFR) and other global regulatory requirements governing dietary supplements or pharmaceutical products. Strong attention to detail and ability to prioritize tasks effectively in a fast-paced environment. Excellent written and verbal communication skills, with the ability to interact confidently with internal teams and regulatory agencies. Proven experience with regulatory submissions, regulatory agency interactions, and compliance activities. Regulatory affairs certification (e.g., RAC) or equivalent credentials desirable but not mandatory. Lief is an Equal Opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, or sex, including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house product development and R&D team creates the best-tasting and cutting-edge supplement formulations. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for many supplement categories. The
Quality Regulatory Affairs Specialist
will be a key contributor to ensuring full compliance with regulatory standards while upholding the highest levels of product quality. You will collaborate closely with cross-functional teams to ensure adherence to current Good Manufacturing Practices (cGMP) and all applicable regulatory requirements. Summary
The ideal candidate is well-versed in 21 CFR Part 111, USDA, FTC, and other regulatory standards as needed. Success in this position requires strong attention to detail, excellent communication skills, and a solid understanding of regulatory affairs within the nutraceutical and dietary supplement industry. Responsibilities
Review and approve raw material, packaging material, and finished product specifications, supplement facts panels, and labeling to ensure compliance with applicable regulations. Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle, from development to commercialization. Collaborate with R&D and Quality teams to assess formulations and claims for regulatory compliance. Maintain and update regulatory documentation, including formulation sheets, product registrations, and master files. Review/Approval of Master Manufacturing Record/Master Batch Record Shelf-life / Stability Data Oversight Claims Substantiation Risk Register / Label Approval Workflow Regulatory Requests Respond to client inquiries regarding formulas, including questions on claim substantiation, GRAS status, NDI compliance, and related regulatory matters. Review supplier-provided raw material and packaging material documentation. Collaborate cross-functionally with Procurement and R&D to qualify suppliers by reviewing and validating onboarding documentation. Collaborate with Lief’s Organic Certifier to ensure full compliance with the USDA National Organic Program. Collaborate with Lief’s Halal and Kosher Certifiers to ensure full compliance with their standards. Support customers in obtaining or maintaining certifications such as NSF, USP, Non-GMO Project Verified, USDA Organic, Kosher, Halal, Gluten-Free, Informed Sport, or Prop 65 compliance. Monitor changes in regulations and guidance documents issued by regulatory authorities and communicate updates to relevant stakeholders. Participate in continuous improvement initiatives to enhance regulatory processes and ensure alignment with industry best practices. Provide training and support to employees on document control procedures, system usage, cGMP and employee hygiene on an annual basis. Educate internal teams (QA, R&D, marketing) on current regulatory requirements. Act as the point of contact with certification bodies and auditors during application, renewal, or surveillance processes. Manage and maintain facility licenses and certifications, ensuring compliance with local, state, and federal regulatory requirements. Minimum Qualifications
Education/Knowledge : Education: Bachelor's degree in a relevant scientific discipline (e.g., chemistry, biology, pharmacy) required; advanced degree preferred. Minimum of 3 years of experience in regulatory affairs within the dietary supplement, pharmaceutical, food and beverage or related industry. Thorough understanding of FDA regulations (21 CFR) and other global regulatory requirements governing dietary supplements or pharmaceutical products. Strong attention to detail and ability to prioritize tasks effectively in a fast-paced environment. Excellent written and verbal communication skills, with the ability to interact confidently with internal teams and regulatory agencies. Proven experience with regulatory submissions, regulatory agency interactions, and compliance activities. Regulatory affairs certification (e.g., RAC) or equivalent credentials desirable but not mandatory. Lief is an Equal Opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, or sex, including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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