Registered Pharmacist

CNT Promo & Ads Specialist, Inc.; Caloocan; On-site; PHP 300,000 - 460,000; Full time

Job summary

CNT Promo & Ads Specialist, Inc. is seeking a Quality Assurance / Regulatory Affairs Associate to support pharmaceutical, medical device, cosmetic, and manufacturing operations with a focus on regulatory compliance and documentation management.

The role involves developing SOPs, maintaining QMS, supporting FDA submissions, and conducting GMP training for staff. A self-starter who can coordinate with auditors and suppliers will thrive in this environment.

Qualifications

• Proficient in drafting and reviewing technical documentation.
• Strong understanding of GMP and quality systems.
• Excellent documentation management and regulatory submissions skills.

Responsibilities

• Develop, review, revise, and implement SOPs in line with regulatory requirements and company practices.
• Prepare, review, organize, and maintain quality and regulatory documentation.
• Assist with product registration files, LTO applications, and other submissions to the Philippine FDA.
• Monitor regulatory requirements, FDA issuances, and ensure timely compliance and alignment of documents.
• Support GMP, GDP and other quality systems implementation at the manufacturing plant.
• Maintain the Quality Management System including document control and records management.
• Support internal audits, regulatory inspections, and follow-up on action items.
• Provide GMP training for new staff and refreshers for existing staff.
• Assist in new product development with regulatory checks and documentation support.
• Ensure proper filing, safekeeping, retention, and retrieval of records.

Education

Registered Pharmacist with PRC license

Job description

About the role

Quality Assurance / Regulatory Affairs Associate supporting pharmaceutical, medical device, cosmetic, and manufacturing operations with focus on regulatory compliance, documentation management, and quality systems implementation.

Key responsibilities

• Assist in the development, review, revision, and implementation of Standard Operating Procedures (SOPs), ensuring alignment with regulatory requirements and company practices.
• Support QA/RA activities by preparing, reviewing, organizing, and maintaining quality and regulatory documentation.
• Support in the application of product registration files, License to Operate (LTO) applications, and other submissions to the Philippine Food and Drug Administration.
• Monitor regulatory requirements, FDA issuances, and updates, and assist in ensuring timely compliance and document alignment.
• Participate in the implementation and monitoring of GMP, GDP, and other quality systems within the manufacturing plant.
• Assist in maintaining the Quality Management System (QMS), including documentation control, records management, and support during management reviews.
• Support internal audits, regulatory inspections, and compliance activities, including preparation of documents and follow-up of action items.
• Conduct GMP training for new employees and assist in providing refresher and competency training for existing staff.
• Assist in new product development activities by supporting documentation, regulatory requirements, and compliance checks.
• Ensure proper filing, safekeeping, retention, and retrieval of quality and regulatory records.

About you

• Must be a Registered Pharmacist with a valid PRC license.
• Experience in QA / Regulatory Affairs of pharmaceutical, medical device, cosmetic, HUHS, or manufacturing operations is an advantage.
• Understanding of GMP (Good Manufacturing Practice) to effectively monitor and implement quality systems.
• Ability to systematically organize complex quality assurance documentation, registration files, and multi-step applications for government agencies.
• Proficiency in drafting and reviewing technical documentation, with the professional clarity required to coordinate with suppliers, clients, and regulatory auditors.
• A keen eye for detail to ensure that documentation and company policies are accurate, complete, and aligned with regulatory timelines and FDA requirements.
• Must be a self-starter, proactive, and able to take initiative in carrying out assigned tasks with minimal supervision.