FDA-Qualified Regulatory Lead – Cosmetics & Devices (Onsite)

Kimtan Labs; Taguig; On-site; PHP 900,000 - 1,500,000; Full time

Job summary

Kimtan Labs is seeking a versatile, licensed regulatory professional to serve as the FDA Registered Qualified Person and lead integrated Regulatory Affairs, IP, 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.

This onsite role is based in the BGC Office and requires strong English and Filipino communication, as well as

Qualifications

• Must be a Registered Pharmacist and eligible to act as FDA Qualified Person.
• Deep knowledge of RA 9711, IP Code, and ASEAN cosmetic/medical device directives.
• Fluent in English and Filipino with strong written and verbal communication.

Responsibilities

• Serve as FDA-registered Qualified Person using the PRC license for regulatory compliance.
• Prepare and manage LTO, CPR, CPN, CMDN/CMDR across food, cosmetics, devices, and pesticides.
• Review labeling, dossiers, SDS, COA for pre-market compliance.
• Monitor e-commerce platforms and issue IP takedowns for infringements.
• Adapt product dossiers for ASEAN markets per harmonized guidelines and target standards.
• Coordinate with foreign firms and counsel to assemble documents for foreign entities.
• Oversee post-market surveillance and pharmacovigilance, including adverse event reporting.

Skills

Regulatory affairs

IP filings

Philippine FDA compliance

Cross-functional coordination

Education

Licensed Pharmacist (PRC)

Job description

Kimtan Labs is seeking a versatile, licensed regulatory professional to serve as the FDA Registered Qualified Person and lead integrated Regulatory Affairs, IP, 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.

This onsite role is based in the BGC Office and requires strong English and Filipino communication, as well as