Regulatory Affairs Director

apartmentKSearch Asia Consulting, Inc. placeManila scheduleFull-time calendar_month 
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!

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