JOB DESCRIPTION
- Lead all regulatory activities in the Philippines including product registrations, renewals,
variations, and post-approval requirements for pharmaceutical, biologic, and medical
device products.
• Ensure compliance with FDA regulations and guidelines, including timely submissions and
responses to regulatory queries.
• Build and maintain strong working relationships with regulatory authorities, industry
associations, and principal clients.
• Oversee preparation, quality review, and submission processes to support timely product
launches and lifecycle management.
• Monitor changes in local regulatory requirements and communicate updates to internal
teams and external partners.
• Support client onboarding and business development efforts by providing regulatory
insights and feasibility assessments.
• Lead audits, inspections, and internal reviews to ensure inspection readiness and
regulatory compliance.
• Manage, mentor, and develop a high-performing regulatory affairs team with clear KPIs and
accountability 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.
ACTIVE DATES
Urgent hiring!
