Regulatory Affairs Director

3 days ago

Manila, Philippines KSearch Asia Consulting, Inc. Full time

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‑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 #J-18808-Ljbffr

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