Pharmacist

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

Are you an experienced Pharmacist or Regulatory Specialist passionate about driving regulatory excellence, maintaining corporate compliance, and ensuring seamless product approvals? We are seeking a proactive, detail-oriented FDA Compliance Pharmacist / Specialist to lead our regulatory submission workflows, manage product registration pipelines, and ensure full alignment with FDA Philippines standards and international quality guidelines.

Key Responsibilities

Regulatory Submissions & LTO Management

• Prepare, compile, submit, and track applications for License to Operate (LTO) and Certificates of Product Registration (CPR) for cosmetic, pharmaceutical, food, or medical device lines with the FDA Philippines.

• Monitor renewal timelines for all corporate licenses and product registrations to ensure zero downtime or disruption in business operations.

• Serve as the official corporate representative and primary Liaison Officer in coordinating with the Food and Drug Administration (FDA), Department of Health (DOH), and other regulatory agencies.

Quality Assurance & Compliance Monitoring

• Oversee and implement Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Storage Practice (GSP) across warehouse and office facility operations.

• Review and approve packaging materials, product labels, marketing claims, and artwork mockups to ensure strict compliance with FDA labeling rules and consumer protection guidelines.

• Lead internal quality audits, standard operating procedure (SOP) formulation, and manage FDA post-market surveillance or audit inspections.

Product Management & Inter-departmental Support

• Collaborate closely with Supply Chain, R&D, Logistics, and Sales teams to evaluate technical documents (COA, MSDS, Product Data Sheets) for incoming raw materials or finished goods.

• Monitor updates on FDA circulars, administrative orders, and regulatory policy shifts to advise management on operational risks and required process adjustments.

• (Optional: Add specific company-tailored duties here based on internal operational requirements.)

Qualifications & Requirements

• License: Registered Pharmacist (PRC License holder) is preferred / required.

• Experience: 2–5+ years of solid experience in Regulatory Affairs, Quality Assurance, or FDA Compliance within cosmetics, pharmaceuticals, food supplements, or consumer goods.

• Knowledge Base: Deep familiarity with FDA Philippines e-portal operations, eLTO, eCPR processes, ASEAN Cosmetic Directive (ACD), or local DOH guidelines.

• Skills: Exceptional written and verbal communication skills, strong attention to detail, and a proactive problem‑solving mindset.

• Ability to handle multi-company compliance workflows in a fast‑paced environment.

Why Join Us?

• Competitive salary package commensurate with experience.

• Career growth and leadership opportunities in a expanding multi-company group.

• Collaborative, output‑focused working environment.