Premier Research Labs · 1 month ago
Regulatory Affairs (1320)
Austin, TX
Full-time
Onsite
Senior Level
5+ years expPremier Research Labs is committed to transforming global wellness through high standards of quality and innovation. The Regulatory Compliance Manager ensures that all products, operations, and communications comply with FDA, FTC, and state regulations for dietary supplements, while facilitating collaboration and maintaining the company's reputation as a leader in whole-body health.
BiotechnologyFitnessHealth CareLife ScienceMedical
Responsibilities
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) 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 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
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
Qualification
Required
Bachelor's degree in Regulatory Affairs, Food Science, Nutrition, Chemistry, or related field
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
Preferred
Master's degree in Regulatory Affairs, Food Science, Nutrition, Chemistry, or related field
Company
Premier Research Labs
Premier Research Labs is a health & wellness company specializing in non-toxic products.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
J. A. (Jack) Leach
Chief Executive Officer
Nickolas Labinsky
Chief Operations Officer
Company data provided by crunchbase