About the role

We are looking for a Regulatory Affairs and Quality Assurance Manager to lead regulatory compliance and quality assurance across our operations. Based in Pasay City, this role ensures all products meet FDA and ISO standards while supporting business growth in the Philippine market.

Key Responsibilities

• Ensure valid FDA certifications (CPR, LTO) for all products and registrations
• Oversee regulatory processes: new applications, renewals, variations, and promo permits
• Represent the company in FDA inspections (Medical Device and HUHS)
• Lead ISO compliance and quality audits for manufacturing and distribution
• Develop and maintain SOPs aligned with FDA and ISO standards
• Manage company-wide document control through Quality Management System
• Act as final approver for after-sales complaints and ensure internal reporting
• Liaise with regulatory counterparts and assist in government inspections
• Ensure compliance with the National Privacy Commission

• Licensed Pharmacist with a BS in Pharmacy
• 3–5 years experience in Regulatory Affairs and Quality Assurance
• Background in manufacturing or distribution (ISO-certified preferred)
• Proficient in FDA, ISO, and OMB permit regulations
• Strong communication, leadership, and analytical skills
• Proficient in Microsoft Office and regulatory software