FDA Regulatory Lead & Compliance Strategist

INSPI Philippine; Quezon City; On-site; PHP 800,000 - 1,100,000; Full time

Job summary

INSPI Philippine is seeking a Regulatory Officer to manage the Regulatory Affairs and Compliance function, ensuring FDA compliance across products and operations. The role drives regulatory strategies, resolves issues, and serves as the primary authority on regulatory matters.

This position requires proactive risk identification, solution implementation, and inspection-ready compliance with minimal oversight.

Qualifications

• 3–5 years of FDA regulatory and compliance experience.
• 3+ years of leadership experience managing regulatory or compliance teams.
• Experience handling FDA inspections, compliance issues, product registrations, renewals, and regulatory submissions.
• Strong network within regulatory and industry circles.

Responsibilities

• Act as escalation point for complex regulatory issues.
• Ensure ongoing FDA and government compliance.
• Oversee compliance of all registered, applied, and marketed products.
• Lead investigations and corrective actions for regulatory findings.
• Prepare for FDA inspections and regulatory reviews.
• Collaborate with Quality, Operations, R&D, Marketing, and Supply Chain.

Skills

FDA regulatory experience

Leadership

FDA inspections

Regulatory submissions

Risk assessment

Strategic thinking

Job description

INSPI Philippine is seeking a Regulatory Officer to manage the Regulatory Affairs and Compliance function, ensuring FDA compliance across products and operations. The role drives regulatory strategies, resolves issues, and serves as the primary authority on regulatory matters.

This position requires proactive risk identification, solution implementation, and inspection-ready compliance with minimal oversight.