Regulatory Pharmacist, Quezon City

General Description of the Position:

The Regulatory Affairs Officer/Quality Officer is responsible for ensuring that the products and practices comply with industry regulations and standards. Maintains the high quality of the products and protects the safety of customers by ensuring that the goods delivered are at its best condition at all times.

List of Specific Duties and Responsibilities:

• Establishes and monitors the standard operating procedures covering receipt, storage/retention, distribution, return, and recall of products.
• Checks all product labels, packaging layouts/pack shots conforming to standards set by regulatory agencies prior to product dispatch of the Manufacturer. 
• Ensures that quality standards are met and submissions meet strict deadlines.
• Coordinates with FDA, BAI, NMIS, and BPI inspectors during routine inspections.
• Conducts self-audits and inspections to identify and address any non-compliance issues. 
• Handles client complaints concerning products, working alongside various departments to facilitate recall efforts when necessary.
• Maintains records and documentation to meet regulatory requirements and internal standards.
• Performs other job-related duties and responsibilities as determined by the immediate head.