Regulatory Pharmacist

Hexagon Healthcare Corporation; Quezon City; On-site; PHP 350,000 - 550,000; Full time

Job summary

A healthcare company is seeking a Regulatory Affairs Officer/Quality Officer responsible for ensuring compliance with industry regulations and maintaining product quality. The role includes establishing standard procedures, coordinating with inspectors, and conducting audits to verify regulatory adherence. Candidates should have experience in regulatory affairs and a strong grasp of standards governing the healthcare industry. This position is crucial in safeguarding customer safety and ensuring high-quality products.

Qualifications

• Experience in regulatory affairs and quality assurance.
• Strong understanding of industry regulations and standards.

Responsibilities

• Establish and monitor standard operating procedures.
• Check product labels and packaging for compliance.
• Coordinate with regulatory inspectors.
• Conduct self-audits to ensure compliance.
• Handle client complaints regarding products.
• 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.

Job description

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.