pharmacist jobs

Company Regulatory Pharmacist – Duties and Responsibilities

Job Summary:
The Regulatory Pharmacist is responsible for ensuring that the company's products, operations, and documentation comply with the requirements of the Food and Drug Administration Philippines and other applicable government regulations. The position oversees product registrations, licensing, regulatory submissions, and compliance monitoring

1. Regulatory Compliance

• Ensure compliance with all FDA regulations, standards, and guidelines.
• Monitor changes in regulatory requirements and advise management on necessary actions.
• Maintain valid permits, licenses, and registrations required for company operations.

2. Product Registration and Licensing

• Prepare, submit, and monitor applications for product registration and renewals.
• Process amendments, variations, and updates to existing product registrations.
• Coordinate with FDA and other regulatory agencies regarding product approvals and compliance matters.

3. Documentation and Record Management

• Maintain accurate and updated regulatory files and records.
• Prepare and review regulatory documents, technical dossiers, and supporting requirements.
• Ensure proper filing and safekeeping of permits, certificates, and regulatory correspondence.

4. Quality Assurance Support

• Assist in developing and implementing quality systems and standard operating procedures (SOPs).
• Participate in internal audits and regulatory inspections.
• Ensure products are handled, stored, and distributed in accordance with regulatory requirements.

5. Government Liaison

• Serve as the company's authorized representative during FDA inspections and audits.
• Coordinate with government agencies regarding compliance issues, product registrations, and licensing concerns.
• Respond to regulatory inquiries, notices, and corrective action requirements.

6. Training and Advisory

• Provide regulatory guidance to management and employees.
• Conduct training on regulatory compliance, good distribution practices, and applicable FDA regulations.
• Advise departments on regulatory implications of new products, promotions, and business activities.

7. Pharmacovigilance and Product Monitoring (if applicable)

• Monitor and report adverse events, product complaints, and recalls.
• Coordinate corrective and preventive actions related to product quality and safety.
• Assist in product recall activities when necessary.

Qualifications

• Licensed Pharmacist with a valid Professional Regulation Commission (PRC) license.
• Knowledge of Philippine FDA regulations and requirements.
• Experience in regulatory affairs, product registration, or quality assurance is preferred.
• Strong attention to detail and documentation skills.
• Excellent communication and coordination abilities.

Reporting

• Acts as the designated Regulatory Pharmacist and FDA Authorized Representative of the company, when applicable.

Pay: Php15,000.00 - Php20,000.00 per month

Benefits:

• Flexible schedule
• Work from home

Work Location: In person