Regulatory Pharmacist

We are seeking a Regulatory Compliance Officer to support our Philippine operations by managing FDA submissions, monitoring regulatory status, and ensuring compliance with packaging standards.

Responsibilities

• Prepare and submit documents to the Philippine Food and Drug Administration (FDA) such as License to Operate (LTO) and ACTD documents for initial registration, site registration/GMP clearance applications, BA/BE study reports, renewal of CPR, and variations.
• Apply for initial and renewal applications for drug products.
• Monitor the status of FDA applications.
• Create and review packaging layouts to align with FDA standards.
• Handle company inspections and audits related to third-party and government agencies.
• Submit trademark applications and manage intellectual property functions with the Intellectual Property Office (IPO).
• Report directly to the Regulatory Manager.

Qualificat...