Regulatory Affairs Director

• Lead all regulatory activities in the Philippines including product registrations, renewals,

• Ensure compliance with FDA regulations and guidelines, including timely submissions and

• Build and maintain strong working relationships with regulatory authorities, industry

• Oversee preparation, quality review, and submission processes to support timely product

• Monitor changes in local regulatory requirements and communicate updates to internal

• Support client onboarding and business development efforts by providing regulatory

• Lead audits, inspections, and internal reviews to ensure inspection readiness and

• Manage, mentor, and develop a high-performing regulatory affairs team with clear KPIs and

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

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

KSearch Asia Consulting