Responsibilities

Your responsibilities will include:

• Prepares & submits documents to Philippine Food and Drug Administration (FDA) such as License to Operate (LTO) & drug product - ACTD document for Initial registration, Site Registration/GMP Clearance applications, BA/BE study report, renewal of CPR, including variations and compliance of existing products.
• Must know or have an experience applying Initial and renewal application for drug products.
• Monitors the status of applications with the FDA.
• Creates and reviews packaging layouts in line with existing standards set by FDA.
• Handles company inspection and audit relevant to third party and government agencies.
• Handles applications with Intellectual Property Office (IPO) for trademarks and other functions of the agency.
• Directly reports to Regulatory Manager.

Qualifications

To be successful in this role, you will need to have: