Regulatory & Quality Assurance Specialist

JS Unitrade Merchandise, Inc.; Eastern Manila District; Sur place; PHP 600 000 - 900 000; Plein temps

Résumé du poste

JS Unitrade Merchandise, Inc. in Metro Manila is seeking a Regulatory & Quality Assurance Specialist to ensure that products, processes, and operations comply with applicable regulatory requirements and quality standards.

You will manage regulatory submissions, licenses, permits, and compliance documentation, support audits and inspections, and act as a liaison with regulatory authorities while guiding cross-functional teams to maintain continuous compliance.

Qualifications

• Bachelor’s Degree in Pharmacy.
• PRC License holder.
• Minimum of 2–3 years of experience in Regulatory Affairs, Quality Assurance, or Compliance.
• Experience handling Medical Devices and Cosmetics is an advantage.
• Familiarity with trademark processes and intellectual property management is an advantage.
• Knowledge of EPR regulations and sustainability reporting is preferred.
• Strong organizational, documentation, and attention-to-detail skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively with cross-functional teams in a fast-paced and collaborative environment.

Responsabilités

• Ensure compliance with FDA, DTI, EPR, and other regulatory requirements.
• Prepare, submit, and maintain product registrations, licenses, permits, and regulatory documents.
• Monitor regulatory updates and provide guidance to relevant teams.
• Facilitate DTI permits, trademark monitoring, and EPR compliance and reporting.
• Review product labels, packaging, and marketing materials for regulatory compliance.
• Monitor and ensure timely resolution and proper documentation of consumer complaints.
• Maintain compliance records and support audits, inspections, and CAPA implementation.
• Act as liaison with regulatory authorities and provide regulatory support to cross-functional teams.
• Review and improve regulatory and quality processes to ensure efficiency and continuous compliance.

Formation

Bachelor's Degree in Pharmacy

Description du poste

Job Description

The Regulatory & Quality Assurance Specialist is responsible for ensuring that products, processes, and operations comply with applicable regulatory requirements, quality standards, and industry guidelines. The role manages regulatory submissions, licenses, permits, and compliance documentation while supporting audits, inspections, and quality assurance activities.

This position also provides guidance on regulatory requirements, works closely with cross-functional teams to maintain compliance, and serves as a key liaison with regulatory authorities. The role handles product complaints and supports the proper evaluation, resolution, and documentation of quality and regulatory concerns.

Key Responsibilities

• Ensure compliance with FDA, DTI, EPR, and other regulatory requirements.

• Prepare, submit, and maintain product registrations, licenses, permits, and regulatory documents.

• Monitor regulatory updates and provide guidance to relevant teams.

• Facilitate DTI permits, trademark monitoring, and EPR compliance and reporting.

• Review product labels, packaging, and marketing materials for regulatory compliance.

• Monitor and ensure timely resolution and proper documentation of consumer complaints.

• Maintain compliance records and support audits, inspections, and CAPA implementation.

• Act as liaison with regulatory authorities and provide regulatory support to cross-functional teams.

• Review and improve regulatory and quality processes to ensure efficiency and continuous compliance.

Qualifications

• Bachelor’s Degree in Pharmacy.

• PRC License holder.

• Minimum of 2–3 years of experience in Regulatory Affairs, Quality Assurance, or Compliance.

• Experience handling Medical Devices and Cosmetics is an advantage.

• Familiarity with trademark processes and intellectual property management is an advantage.

• Knowledge of EPR regulations and sustainability reporting is preferred.

• Strong organizational, documentation, and attention-to-detail skills.

• Excellent communication and interpersonal skills.

• Ability to work effectively with cross-functional teams in a fast-paced and collaborative environment.