Regulatory & Documentation Specialist

Role Summary

We are seeking a detail-oriented Regulatory & Documentation Specialist to join our growing, family-owned organization. Serving as an advanced specialist tier within our Quality and Regulatory team, this position plays a critical role in pre-launch product preparation, regulatory readiness, ingredient/label compliance, and technical document control.This role bridges QA and Regulatory Affairs (typically a 75/25 balance day-to-day). You will go beyond routine SOP updates to lead complex change control processes, build and manage Product Master Files, review formula sheets, evaluate ingredient and label compliance (including FDA Drug Facts Boxes), and prepare dossiers to ensure compliance across US and Canadian markets.

Responsibilities

QA Document Control & Master FilesRegulatory Affairs, Labeling & SubmissionsAdvanced Change ControlQuality & Technical ReviewFDA OTC & Monograph ComplianceGlobal & Regional Ingredient ReviewRegulatory Monitoring & MaintenancePerks:Competitive Salary Full Benefit PlanHybrid Work Environment