Branch Regulatory Pharmacist

Philusa Corporation; Philippines; On-site; PHP 480,000 - 720,000; Full time

Job summary

Philusa Corporation seeks a Regulatory Affairs officer with a BS Pharmacy and PRC license to oversee compliance, licensing, and product registrations. The role involves maintaining regulatory records and coordinating with QA, sales, and supply chain.

The incumbent will manage quality assurance activities, handle product complaints, and serve as Pollution Control Officer for DENR-EMB and Safety Officer for the branch. Experience in regulatory affairs is preferred.

Qualifications

• Maintains government licenses, permits, and registrations.
• Creates and maintains regulatory documentation.
• Coordinates with QA, Regulatory Affairs, Sales, and Supply Chain.
• Manages non-conformance reports and product inspections.

Responsibilities

• Ensuring compliance with renewal of government licenses, permits, and ordinances.
• Maintaining a systematic file of all government licenses, product registrations and certifications.
• Recording and updating the Dangerous Drugs Record Book and Controlled Precursors and Essential Chemicals Record Book; monitor guidelines.
• Coordinating with QA, Regulatory Affairs, Sales, and Supply Chain departments.
• Performing quality assurance tasks, including NCRs and random incoming goods inspections.
• Handling Product Quality Complaints, ADR/AE; acts as Pollution Control Officer for DENR-EMB and Safety Officer.

Skills

Regulatory compliance

Documentation

Quality assurance

Cross-functional coordination

Education

BS Pharmacy

Job description

The candidate will be responsible for the following:

• Ensuring compliance with the renewal of government licenses, permits, and ordinances;
• Maintaining a systematic file of all government licenses, product registrations and certifications;
• Recording and updating the Dangerous Drugs Record Book and Controlled Precursors and Essential Chemicals Record Book. Keeping abreast of new government guidelines and circulars;
• Coordinating with internal departments such as the Quality Assurance and Regulatory Affairs Department, Sales Department, and Supply Chain Department;
• Performing quality assurance function, which includes creating Non-Conformance Reports and performing random inspections on all incoming goods and product returns;
• Handling Product Quality Complaints, Adverse Drug Reaction/Adverse Drug Event; will be the Pollution Control Officer for DENR-EMB and Safety Officer of the branch;
• Admin and other OCT functions such as cashiering, petty cash custodian, process MRS and Consignment Replenishments.

He/She must also meet the following qualifications:

• BS Pharmacy graduate
• PRC License holder