FDA Compliance Pharmacist — Regulatory Affairs Lead

Private Advertiser; Las Piñas; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Private Advertiser seeks an FDA Compliance Pharmacist/Specialist to lead regulatory submissions and ensure full alignment with FDA Philippines standards for cosmetics, pharmaceuticals, and medical devices. You will manage LTO and CPR processes, supervise GMP/GDP/GSP across facilities, review labels and claims, and coordinate with FDA, DOH, and other agencies.

The role requires a PRC-licensed pharmacist with 2–5+ years in Regulatory Affairs or FDA compliance and a proactive, detail‑oriented

Qualifications

• Licensed pharmacist (PRC) or registered pharmacist preferred/required.
• 2–5+ years of solid experience in Regulatory Affairs, QA, or FDA Compliance in cosmetics, pharmaceuticals, or consumer goods.
• Deep familiarity with FDA Philippines e-portal operations, eLTO, eCPR processes, ASEAN Cosmetic Directive (ACD) or local DOH guidelines.
• Strong written and verbal communication, detail‑oriented, proactive problem solving.
• Ability to manage multi‑company compliance workflows in a fast‑paced environment.

Responsibilities

• Prepare, submit, and track LTO and CPR applications for product lines with FDA Philippines.
• Monitor renewal timelines to maintain zero downtime of licenses and registrations.
• Coordinate as liaison with FDA, DOH, and other regulatory agencies.
• Oversee GMP, GDP, and GSP across storage and office facilities.
• Review packaging, labels, marketing claims, and artwork for regulatory compliance.
• Lead internal quality audits and SOP development.

Skills

Regulatory Affairs

Quality Assurance

FDA Compliance

Attention to detail

Communication

Education

PRC Pharmacist License

Job description

Private Advertiser seeks an FDA Compliance Pharmacist/Specialist to lead regulatory submissions and ensure full alignment with FDA Philippines standards for cosmetics, pharmaceuticals, and medical devices. You will manage LTO and CPR processes, supervise GMP/GDP/GSP across facilities, review labels and claims, and coordinate with FDA, DOH, and other agencies.

The role requires a PRC-licensed pharmacist with 2–5+ years in Regulatory Affairs or FDA compliance and a proactive, detail‑oriented