Regulatory Affairs Specialist

About This Role

The Regulatory Affairs Specialist ensures that all corporate licenses and product clearances comply with FDA standards. This role involves preparing and submitting applications, managing regulatory communications, and maintaining an organized archiving system for all compliance documents.

Responsibilities

• Prepare, review, and submit accurate applications for initial issuance, renewal, and operational amendments of corporate Licenses to Operate (LTO) as Manufacturer, Distributor/Importer, Trader, and Retailer across all managed entities and product categories
• Secure, manage, and renew product-level clearances, including Certificates of Product Notification (CPN) for Cosmetics, Certificates of Product Registration (CPR) for Beverages and Food, Certificates for Medical Devices (CMD/CMDR), and authorizations for Household/Urban Hazardous Substances (HUHS) and Drugs/Drugstores
• Conduct technical reviews of formulations, raw materials, safety profiles, and labeling/packaging materials prior to commercial launch to ensure absolute alignment with FDA standards and authorized product claims
• Oversee the submission and approval of initial applications, renewals, and amendments for Sales Promo Permits with the FDA, ensuring marketing campaigns comply with fair trade and consumer protection regulations
• Monitor, manage, and resolve all regulatory communications from the FDA, including formal letters of compliance, notices of deficiency, and regulatory advisories, ensuring accurate and prompt corrective responses
• Maintain a centralized, audit-ready archiving system for all submission dossiers, official approvals, government receipts, and agency correspondence across all company entities; continuously monitor changes in health regulations and administrative orders
• Act as the registered Qualified Person / Authorized Representative for the company during FDA inspections, technical inquiries, and agency coordinates
• Oversee day-to-day regulatory workflow, ensuring high-quality submissions and adherence to strictly enforced internal and government timelines

Requirements

• Graduate of BS Pharmacy
• Must be a registered Pharmacist
• At least two years of experience
• Newly graduates are welcome to apply

Important Details

• Start date: ASAP