REGULATORY COORDINATOR

This is a fantastic opportunity to join GoldenStars Packaging Resources Co., Inc. as a Regulatory Coordinator. In this full-time role, you will be involved in manages a company’s compliance with government laws, industry standards, and internal policies

Qualifications

• Bachelor's degree in Food Technology, Pharmacy, Chemistry, Biology, Microbiology, Nutrition, Chemical Engineering, or any related science course.
Experience or training in regulatory affairs, FDA compliance, product registration, permit processing, or quality assurance is preferred.
• QPIRA (Qualified Person in Industry Regulatory Affairs) training/certification is an advantage, particularly in the applicable FDA regulatory area.
• Knowledge of FDA regulations, GMP, HACCP, ISO 22000/FSSC 22000, and product registration/notification processes.
• Knowledge and experience in processing and monitoring government permits and regulatory clearances, including but not limited to FDA permits, Business/Mayor's Permit, Sanitary Permit, Building Permit, Fire Safety Inspection Certificate (FSIC), Environmental permits/clearances, and other permits required for company operations.
• Able to coordinate with various government agencies and regulatory offices, including the FDA, LGU, BFP, DENR, and other relevant agencies.
• Willing and capable of processing, renewing, monitoring, and maintaining all company permits, licenses, certificates, and regulatory requirements within prescribed deadlines.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Strong attention to detail with excellent documentation and organizational skills.
• Excellent written and verbal communication skills.
• Able to work independently, coordinate with different departments, and follow up with government offices regarding applications, renewals, inspections, and regulatory concerns.
• Willing to attend government meetings, inspections, hearings, seminars, and other regulatory activities when required.
• Ability to work under pressure and meet strict regulatory deadlines.

Preferred Skills

• Experience in processing FDA License to Operate (LTO), Certificate of Product Registration (CPR), product notifications, and permit renewals.
• Experience in processing or coordinating LGU permits, Building Permit, Sanitary Permit, Fire Safety Inspection Certificate (FSIC), Environmental permits/clearances, and other regulatory permits.
• Knowledge of document control and regulatory compliance systems.
• Familiarity with online government regulatory portals and electronic submission systems.
• Strong follow-up and coordination skills when dealing with government agencies.
• QPIRA training/certification in Food or other applicable FDA regulatory areas.