Premier Research Labs
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Regulatory Affairs (1320)
role at
Premier Research Labs
The Regulatory Compliance Manager safeguards Premier Research Labs’ commitment to transforming global wellness by setting extraordinary standards of quality and innovation. This role ensures compliance with FDA, FTC, and state regulations for dietary supplements, embodying PRL’s core values: Transformation, Extraordinary, and Community.
Through collaboration, oversight, and proactive regulatory intelligence, the individual ensures PRL’s systems and documentation consistently exceed expectations—protecting consumers and reputation.
Key Responsibilities Regulatory Compliance Oversight
Lead day-to-day compliance activities for manufacturing, labeling, and marketing practices in accordance with DSHEA, FDA cGMP (21 CFR Part 111), 21 CFR Part 101, and FTC advertising regulations.
Conduct regular internal compliance reviews to ensure adherence to company SOPs, product specifications, and federal/state regulations.
Monitor industry guidance, enforcement trends, and policy changes, communicating critical updates to leadership and relevant departments.
Coordinate responses to agency inquiries, audits, and inspections, ensuring timely, accurate, and transparent communication.
Ensure PRL maintains all necessary regulatory registrations, certifications, and records required for operations.
Labeling & Claims Compliance
Review and approve product labels, packaging, and marketing materials to ensure compliance with FDA and FTC regulations and alignment with PRL’s standards for accuracy, truth, and scientific integrity.
Verify that structure/function claims, nutrient content claims, and product benefits are substantiated by competent and reliable scientific evidence.
Maintain and update PRL’s claims substantiation files, ensuring all claims are documented and defensible.
Partner with Marketing, Product Development, and Legal to proactively prevent non-compliance before publication or product launch.
Audit, Documentation, & Training
Lead and coordinate internal audits of labeling, documentation, and manufacturing compliance.
Develop and implement Corrective and Preventive Actions (CAPAs) for any deviations or findings, ensuring accountability and follow-through.
Oversee maintenance of all regulatory documentation, including SOPs, labeling records, inspection reports, and compliance logs.
Conduct compliance training sessions for cross‑functional teams (e.g., QA, Marketing, R&D, and Customer Support) to promote a culture of shared responsibility for quality and compliance.
Support preparation and readiness for third‑party and regulatory inspections (FDA, NSF, state health departments, etc.).
Cross‑Functional Collaboration
Partner with Product Development and Quality Assurance to confirm ingredients, formulas, and manufacturing practices meet all regulatory requirements.
Collaborate with QC and QA to monitor testing programs, ensuring that purity, potency, and identity requirements are maintained and properly documented.
Serve as a regulatory resource to Marketing, ensuring claims are creative yet compliant, and reflect PRL’s commitment to truth and transformation.
Support vendor and contract manufacturer oversight to ensure external partners uphold PRL’s standards for compliance and integrity.
Continuous Improvement & Systems Leadership
Lead initiatives to modernize PRL’s compliance infrastructure, ensuring systems and documentation remain audit‑ready at all times.
Identify opportunities for improvement within labeling workflows, change control, and product approval processes.
Maintain an open feedback loop with leadership, ensuring that compliance is viewed as a strategic enabler of innovation and growth—not just a control mechanism.
Qualifications Required Qualifications & Skills
Bachelor’s degree in Regulatory Affairs, Food Science, Nutrition, Chemistry, or related field (Master’s preferred).
Minimum 5+ years of experience in regulatory compliance or quality assurance within the dietary supplement, nutraceutical, or pharmaceutical industry.
Comprehensive knowledge of DSHEA, 21 CFR Part 111, 21 CFR Part 101, FTC advertising standards, and relevant state regulations.
Experience conducting internal or external audits and implementing CAPAs.
Strong organizational skills with a high degree of attention to detail and accuracy.
Excellent communication and training skills to articulate regulatory requirements across diverse teams.
Proven ability to manage multiple projects simultaneously in a fast‑paced, high‑growth environment.
Deep personal alignment with PRL’s mission and values of Transformation, Extraordinary, and Community.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Legal
Wellness and Fitness Services
#J-18808-Ljbffr
Regulatory Affairs (1320)
role at
Premier Research Labs
The Regulatory Compliance Manager safeguards Premier Research Labs’ commitment to transforming global wellness by setting extraordinary standards of quality and innovation. This role ensures compliance with FDA, FTC, and state regulations for dietary supplements, embodying PRL’s core values: Transformation, Extraordinary, and Community.
Through collaboration, oversight, and proactive regulatory intelligence, the individual ensures PRL’s systems and documentation consistently exceed expectations—protecting consumers and reputation.
Key Responsibilities Regulatory Compliance Oversight
Lead day-to-day compliance activities for manufacturing, labeling, and marketing practices in accordance with DSHEA, FDA cGMP (21 CFR Part 111), 21 CFR Part 101, and FTC advertising regulations.
Conduct regular internal compliance reviews to ensure adherence to company SOPs, product specifications, and federal/state regulations.
Monitor industry guidance, enforcement trends, and policy changes, communicating critical updates to leadership and relevant departments.
Coordinate responses to agency inquiries, audits, and inspections, ensuring timely, accurate, and transparent communication.
Ensure PRL maintains all necessary regulatory registrations, certifications, and records required for operations.
Labeling & Claims Compliance
Review and approve product labels, packaging, and marketing materials to ensure compliance with FDA and FTC regulations and alignment with PRL’s standards for accuracy, truth, and scientific integrity.
Verify that structure/function claims, nutrient content claims, and product benefits are substantiated by competent and reliable scientific evidence.
Maintain and update PRL’s claims substantiation files, ensuring all claims are documented and defensible.
Partner with Marketing, Product Development, and Legal to proactively prevent non-compliance before publication or product launch.
Audit, Documentation, & Training
Lead and coordinate internal audits of labeling, documentation, and manufacturing compliance.
Develop and implement Corrective and Preventive Actions (CAPAs) for any deviations or findings, ensuring accountability and follow-through.
Oversee maintenance of all regulatory documentation, including SOPs, labeling records, inspection reports, and compliance logs.
Conduct compliance training sessions for cross‑functional teams (e.g., QA, Marketing, R&D, and Customer Support) to promote a culture of shared responsibility for quality and compliance.
Support preparation and readiness for third‑party and regulatory inspections (FDA, NSF, state health departments, etc.).
Cross‑Functional Collaboration
Partner with Product Development and Quality Assurance to confirm ingredients, formulas, and manufacturing practices meet all regulatory requirements.
Collaborate with QC and QA to monitor testing programs, ensuring that purity, potency, and identity requirements are maintained and properly documented.
Serve as a regulatory resource to Marketing, ensuring claims are creative yet compliant, and reflect PRL’s commitment to truth and transformation.
Support vendor and contract manufacturer oversight to ensure external partners uphold PRL’s standards for compliance and integrity.
Continuous Improvement & Systems Leadership
Lead initiatives to modernize PRL’s compliance infrastructure, ensuring systems and documentation remain audit‑ready at all times.
Identify opportunities for improvement within labeling workflows, change control, and product approval processes.
Maintain an open feedback loop with leadership, ensuring that compliance is viewed as a strategic enabler of innovation and growth—not just a control mechanism.
Qualifications Required Qualifications & Skills
Bachelor’s degree in Regulatory Affairs, Food Science, Nutrition, Chemistry, or related field (Master’s preferred).
Minimum 5+ years of experience in regulatory compliance or quality assurance within the dietary supplement, nutraceutical, or pharmaceutical industry.
Comprehensive knowledge of DSHEA, 21 CFR Part 111, 21 CFR Part 101, FTC advertising standards, and relevant state regulations.
Experience conducting internal or external audits and implementing CAPAs.
Strong organizational skills with a high degree of attention to detail and accuracy.
Excellent communication and training skills to articulate regulatory requirements across diverse teams.
Proven ability to manage multiple projects simultaneously in a fast‑paced, high‑growth environment.
Deep personal alignment with PRL’s mission and values of Transformation, Extraordinary, and Community.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Legal
Wellness and Fitness Services
#J-18808-Ljbffr