Regulatory Affairs Director
KSearch Asia Consulting, Inc. Manila Full-time
JOB DESCRIPTION
device products.
- Lead all regulatory activities in the Philippines including product registrations, renewals,
device products.
- 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
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
- Excellent communication, negotiation, and client-facing skills.
- Strong leadership and people management capabilities.
Urgent hiring!
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