Regulatory QA Pharmacist: Compliance & Documentation Lead

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

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.