Project Coordinator- Regulatory

ETERNA MANAGEMENT, LLC JOB DESCRIPTION Job Title: Project Coordinator – Regulatory Department: Regulatory Affairs / Quality Reports To: [Regulatory Affairs / Quality Manager] Location: 2901 Daimler Street, Santa Ana, CA Employment Type: Full-Time FLSA Classification: Non-Exempt (Hourly) Pay Range: $25.00 – $27.00 per hour Position Summary The Project Coordinator – Regulatory supports Eterna Management, LLC in planning, tracking, and executing projects within a highly regulated manufacturing and third-party logistics (3PL) environment. This role coordinates timelines, documentation, and cross-functional communication to ensure projects are completed accurately, on schedule, and in compliance with applicable federal, state, and local regulations. The ideal candidate is a self-starter who takes initiative without constant direction, is exceptionally detail-oriented, and understands that in a regulatory environment, accuracy and documentation are non-negotiable. Essential Duties and Responsibilities Coordinate and track regulatory, quality, and operational projects from initiation through completion, including timelines, milestones, deliverables, and action items. Maintain organized, audit-ready project files, logs, and records in accordance with company document control and record-retention requirements. Assist with the preparation, review, and submission of regulatory documentation, registrations, renewals, certificates, and compliance reports. Track regulatory deadlines, license and permit renewals, and required filings; proactively notify stakeholders of upcoming due dates. Support internal audits, customer audits, and regulatory inspections by gathering documentation, preparing binders, and tracking corrective and preventive actions (CAPAs) to closure. Coordinate cross-functionally with Quality Control, Production, Lab, Warehouse, Safety, and Management to gather information and keep projects moving. Schedule and facilitate project meetings; prepare agendas, record meeting notes, and distribute and follow up on action items. Review documents, labels, specifications, and records for accuracy, completeness, and consistency, and escalate discrepancies promptly. Assist in drafting, updating, and routing Standard Operating Procedures (SOPs), work instructions, and forms for review and approval. Prepare status reports, trackers, and summaries for leadership on project progress, risks, and open items. Monitor changes in applicable regulations and industry guidance as directed and communicate relevant updates to the team. Maintain confidentiality of proprietary, customer, and regulatory information. Perform other related duties as assigned. Qualifications Education and Experience: High school diploma or equivalent required; Associate's or Bachelor's degree in Business, Science, Regulatory Affairs, or a related field preferred. Minimum of two (2) years of project coordination, administrative, compliance, or quality support experience. Experience in a regulated industry (e.g., dietary supplements, food, cosmetics, pharmaceuticals, hemp/CBD, or medical devices) strongly preferred. Familiarity with cGMP, document control, audit processes, or CAPA systems preferred. Skills and Abilities: Self-Starter: Works independently, takes ownership of assignments, and identifies next steps without waiting for direction. Detail-Oriented: Exceptional accuracy and thoroughness; catches errors and inconsistencies before they become compliance issues. Organized: Strong organizational and time-management skills with the ability to manage multiple projects and deadlines at once. Communicator: Clear, professional written and verbal communication with employees at all levels. Technical: Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint); experience with project-tracking tools is a plus. Integrity: Exercises sound judgment, handles confidential information with discretion, and escalates concerns appropriately. Bilingual (Engli…

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