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Through collaboration, oversight, and proactive regulatory intelligence, this individual ensures that PRL’s systems and documentation consistently exceed expectations — protecting both our consumers and our reputation as a trusted leader in whole-body health.Key Responsibilities
Regulatory Compliance Oversight
- Lead day-to-day compliance activities for PRL’s 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.
- 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.
- Lead and coordinate internal audits of labeling, documentation, and manufacturing compliance.
- Develop and implement Corrective and Preventive Actions (CAPAs)Â 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.).
- Partner with Product Development and Quality Assurance to confirm ingredients, formulas, and manufacturing practices meet all regulatory requirements.
- Collaborate with QC and QAÂ 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.
- 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.
- 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, FTCÂ 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.
Physical Demands & Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Must be able to stand and walk for extended periods.
- Must be able to wear required PPE, which may include safety shoes, hearing protection, and specific sampling-related gear occasionallyÂ
- Monday–Friday 8am-5pm with flexibilityÂ
- Required to be on-site majority of weekÂ
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