JOB SUMMARY:
We are looking for an experienced Regulatory & Quality Lead to drive our regulatory compliance and quality management initiatives across our supply chain operations.
This is a critical role that will lead the company’s FDA and PDEA registrations, establish quality systems, ensure compliance with applicable regulations, and maintain audit readiness. The successful candidate will serve as the subject matter expert for regulatory affairs and quality management while partnering with internal teams and external regulatory agencies.
KEY RESPONSIBILITIES:
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- Lead and manage FDA, PDEA, DOH, Bureau of Customs (BOC), and other regulatory registrations, renewals, and compliance activities.
- Ensure compliance with applicable local and international regulatory requirements, including WHO Good Distribution Practices (GDP), where applicable.
- Develop, implement, and continuously improve Quality Management Systems (QMS), policies, SOPs, and work instructions.
- Establish quality standards and ensure consistent implementation across supply chain operations and service providers.
- Conduct quality and regulatory compliance training for employees and third-party service providers.
- Plan and perform internal quality audits and supplier audits to ensure regulatory compliance.
- Maintain audit-ready documentation and oversee corrective and preventive actions (CAPA).
- Serve as the primary liaison during regulatory inspections and external audits.
- Monitor changes in regulatory requirements and recommend process improvements.
- Work closely with Supply Chain, Warehouse, Procurement, Commercial, and Operations teams to ensure compliance throughout the organization.
QUALIFICATIONS:
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- Bachelor’s Degree in Pharmacy, Industrial Engineering, Supply Chain Management, or a related field.
- Licensed Pharmacist is an advantage but not required.
- At least 5 years of experience in Regulatory Affairs, Quality Assurance, or Quality Management within a regulated industry.
- Proven experience handling FDA and PDEA registrations and compliance is required. Knowledgeable in Philippine regulatory requirements, quality systems, and audit processes. Experience in pharmaceutical, healthcare, medical device, chemical, or regulated distribution industries is highly preferred. And background in developing SOPs, quality policies, and compliance programs.
- Excellent communication, stakeholder management, and project management skills. Able to work independently and lead cross-functional initiatives.
- If being considered with the position, amenable to work onsite at Makati office.
BENEFITS:
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- Competitive salary
- Comprehensive health and dental insurance
- Leaves Benefits
- Performance benefits
- Professional development opportunities
- Collaborative and innovative work environment