QA & Regulatory Affairs Specialist — GMP, FDA Compliance

CNT Promo & Ads Specialist, Inc.; Caloocan; On-site; PHP 360,000 - 600,000; Full time

Job summary

CNT Promo & Ads Specialist, Inc. seeks a Quality Assurance / Regulatory Affairs Associate to support pharmaceutical, medical device, cosmetic, and manufacturing operations. The role focuses on regulatory compliance, documentation management, and quality systems implementation.

Responsibilities include SOP Development, QA/RA documentation, FDA submissions, GMP/GDP adherence, QMS maintenance, audits, and staff training. PRC-licensed pharmacist required; GMP knowledge preferred.

Qualifications

• Registered Pharmacist with PRC license is required.
• Experience in QA/Regulatory Affairs for pharma, medical devices, cosmetics, HUHS, or manufacturing is an advantage.
• Understanding of GMP to monitor and implement quality systems.
• Ability to organize complex QA/RA docs and multi-step government filings.
• Proficient at drafting and reviewing regulatory documentation for suppliers, clients, auditors.
• Keen eye for detail to ensure documentation aligns with regulatory timelines and FDA requirements.
• Self-starter, proactive with minimal supervision.

Responsibilities

• Assist in developing, reviewing, revising, and implementing SOPs aligned with regulatory requirements and company practices.
• Support QA/RA activities by maintaining quality and regulatory documentation.
• Assist in product registration filings, LTO applications, and submissions to the Philippine FDA.
• Monitor regulatory requirements and FDA issuances for timely compliance.
• Participate in GMP, GDP, and other quality systems within the manufacturing plant.
• Maintain the Quality Management System (QMS) documentation and records.
• Support internal audits, regulatory inspections, and follow-up of action items.
• Conduct GMP training for new employees and refreshers for staff.
• Assist in new product development supporting documentation and regulatory compliance.
• Ensure proper filing, safekeeping, retention, and retrieval of records.

Skills

GMP knowledge

QA/RA experience

Documentation organization

Technical documentation

Detail-oriented

Self-starter

Education

Registered Pharmacist with PRC license

Job description

CNT Promo & Ads Specialist, Inc. seeks a Quality Assurance / Regulatory Affairs Associate to support pharmaceutical, medical device, cosmetic, and manufacturing operations. The role focuses on regulatory compliance, documentation management, and quality systems implementation.

Responsibilities include SOP Development, QA/RA documentation, FDA submissions, GMP/GDP adherence, QMS maintenance, audits, and staff training. PRC-licensed pharmacist required; GMP knowledge preferred.