Regulatory Affairs & IP Operations Specialist (FDA Qualified Person)

Position Overview

Kimtan Labs is seeking a versatile, licensed regulatory professional to serve as our FDA Registered Qualified Person and lead integrated Regulatory Affairs, Intellectual Property, and International Market Operations. You will leverage your PRC license for Philippine FDA compliance, manage daily brand protection enforcement, administer IP filings, and project-manage global market expansion.

Key Responsibilities

FDA Regulatory Compliance (Qualified Person)

• Serve as the official FDA-registered Qualified Person using your active PRC license to ensure regulatory compliance across all company operations.
• Prepare, submit, and manage Licenses to Operate (LTO), Certificates of Product Registration (CPR), Cosmetic Product Notifications (CPN), and Medical Device Notifications/Registrations (CMDN/CMDR) across food, drugs, cosmetics, medical devices, and household pesticides/urban hazardous substances.
• Review product labeling, technical dossiers, packaging artwork, Safety Data Sheets (SDS), and Certificates of Analysis (COA) for pre-market compliance.

IP Enforcement & Brand Protection

• Conduct daily digital monitoring across e-commerce platforms (Shopee, Lazada, TikTok Shop) and social channels to issue prompt IP/copyright takedown requests against infringers.
• Prepare and submit trademark and patent applications with IPOPHL, and coordinate international brand filings via WIPO / the Madrid Protocol.
• Track trademark renewal schedules, monitor IP registries, and assist in filing administrative oppositions against unauthorized brand usage.

Global Expansion & Post-Market Surveillance

• Adapt technical product dossiers for export markets using ASEAN harmonized guidelines and target country standards (e.g., HSA Singapore, BPOM Indonesia, US FDA).
• Act as the internal project coordinator liaising with foreign corporate secretarial firms and international legal counsel to assemble documents required for foreign business entity setups.
• Manage post-market surveillance, pharmacovigilance, and cosmetovigilance logs, investigating safety complaints and submitting mandatory adverse event reports.

Qualifications & Requirements

• Professional Registration: Active Philippine PRC License (Registered Pharmacist, Chemist, or qualified allied health professional) eligible and willing to serve as the company's official FDA Qualified Person.
• FDA Submission Expertise: Proven experience navigating the Philippine FDA e-Portal v2 system across food, cosmetics, medical devices, drugs, and household pesticides.
• IP Administration: Hands-on experience with e-commerce platform IP takedown mechanisms and working knowledge of IPOPHL and WIPO registration processes.
• Cross-Functional Operations: Demonstrated ability to project-manage corporate legal/expansion tasks and coordinate with external legal counsels.
• Regulatory Knowledge: Deep understanding of Republic Act 9711 (FDA Act of 2009), the Philippine IP Code, and ASEAN harmonized cosmetic/medical device directives.
• Communication: Exceptional organizational skills with fluent written and verbal communication skills in English and Filipino.