DUTIES AND RESPONSIBILITIES:

1. As Regulatory/Company Pharmacist

Regulatory Compliance and  Registration Management

1. Facilitate timely applications of the products due for registrations (Initial / CLIDP / Renewal / Amendments).
2. Monitor status of registrations and other regulatory applications and ensure follow-up with the Philippine Food and Drug Administration (FDA) on files under review/evaluation.
3. Conduct personal visits to FDA for registration application and follow-ups if needed.
4. Promptly respond to FDA communications or compliance procedures.
5. Proofread and approve all packaging materials before printing.
6. Represent the company during FDA’s routine inspection.
7. Conduct regular inspection of to warehouse facility to ensure proper handling and storage of products.
8. Act as the company representative on regulatory-related matters and coordinate closely with corporate regulatory pharmacist and manufacturer's regulatory department.

Licenses, Clearances and Permits Compliance

1. Ensure that all company licenses to operate are valid at all times.
2. Ensure that pharmaceutical products are batched certified prior to marketing distribution.
3. Preparation of necessary documents needed for Barcode registration for each product.
4. Request and prepare documents for confirmatory analysis/quality testing of products to be registered and the commercial products for distribution through accredited laboratory (CEDRES, UP).

Pharmacovigilance

1. The document, analyze and respond to product complaints and make recommendations.
2. Participate in the Company’s response to adverse event reports and product recalls.
3. Ensure the damaged and expired stocks are disposed of, as per the waste disposal process.

Regulatory support services

1. Coordinates with Sales and Marketing Department on promo campaigns for possible permit applications with FDA.
2. Review promotional, advertising and marketing materials for their regulatory compliance.
3. Undertake necessary research work for application or addition to MIMS product information.

Records and files management

1. Ensure systematic fling, completeness, confidentiality of documents, and compliance to the company’s standards and preparedness during local audits (FDA Inspections).
2. Ensure retention of batch records from each batch of the finished product.

Supplementary roles

1. Prepare and monitor payment requisition to ensure timely settlement of registration fees and related regulatory payables.