JOB DESCRIPTION

• Lead all regulatory activities in the Philippines including product registrations, renewals,variations, and post-approval requirements for pharmaceutical, biologic, and medicaldevice products.
• Ensure compliance with FDA regulations and guidelines, including timely submissions andresponses to regulatory queries.
• Build and maintain strong working relationships with regulatory authorities, industryassociations, and principal clients.
• Oversee preparation, quality review, and submission processes to support timely productlaunches and lifecycle management.
• Monitor changes in local regulatory requirements and communicate updates to internalteams and external partners.
• Support client onboarding and business development efforts by providing regulatoryinsights and feasibility assessments.
• Lead audits, inspections, and internal reviews to ensure inspection readiness andregulatory compliance.
• Manage, mentor, and develop a high-performing regulatory affairs team with clear KPIs andaccountability structures.

JOB QUALIFICATION

• Must be a licensed Pharmacist.
• In-depth understanding of FDA regulations
• Proven track record in handling end-to-end product registration and post-marketing

compliance.

• Excellent communication, negotiation, and client-facing skills.
• Strong leadership and people management capabilities.

Please refer the Job description for details