Regulatory Affairs Lead – Pharma Compliance & QA

Diagnostika Pilipinas, Inc.; Philippines; On-site; PHP 600,000 - 900,000; Full time

Job summary

Diagnostika Pilipinas, Inc. is seeking a Regulatory Affairs/Pharmacist Officer in the Philippines to ensure compliance with FDA, DOH, PDEA, and other regulatory bodies. This desk-based role involves evaluating scientific and legal documents and coordinating licensing activities.

The successful candidate will prepare registrations, oversee QA systems, manage licenses, and liaise with partners while keeping up-to-date with regulations and best practices in the pharmaceutical field.

Qualifications

• Must hold a valid Pharmacist license and degree in Pharmacy.
• Solid knowledge of Philippine FDA, DOH, PDEA regulations.
• Experience with importation, licensing, and product registrations.

Responsibilities

• Serve as Regulatory Affairs liaison between the company and partners.
• Prepare, process, and facilitate registration and licensing of diagnostic products and equipment with FDA/DOH.
• Review product information and licensing activities for all product segments.
• Design and implement regulatory strategies to meet licensing timelines.
• Maintain QA systems, SOPs, and risk management for inventory and shipments.
• Process permits with PDEA for importation and hazardous waste management.

Skills

Regulatory affairs

Licensed Pharmacist

Regulatory compliance

Attention to detail

Communication skills

Education

Bachelor's degree in Pharmacy

Tools

Microsoft Office

Google Sheets

Job description

Diagnostika Pilipinas, Inc. is seeking a Regulatory Affairs/Pharmacist Officer in the Philippines to ensure compliance with FDA, DOH, PDEA, and other regulatory bodies. This desk-based role involves evaluating scientific and legal documents and coordinating licensing activities.

The successful candidate will prepare registrations, oversee QA systems, manage licenses, and liaise with partners while keeping up-to-date with regulations and best practices in the pharmaceutical field.