Regulatory Affairs

QUALITY ASSURANCE:

· Responsible for the final release of products in the absence of Sr. RA/QA Manager.

· Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality Standards

· Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.

· Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.

· Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.

· Follow up with implemented programs (GMPs, Good Hygiene Practices, Cleaning and Sanitation, Pest Control, Equipment Calibration) to ensure compliance by all employees and other personnel in the repacking facility.

· Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.

· Participate in all regulatory, third party and customer audits and inspections, and corrective action response.

· Perform other duties as directed by the RA/QA Department management.

· Maintain compliant and non-conformance processing through records and tracking systems, including root-cause analysis and corrective actions.

· Document quality assurance activities with internal reporting and audits.

REGULATORY AFFAIRS:

DOCUMENTATION

· Prepares and check submissions of License to Operate renewal and other inter-related regulatory correspondence with FDA.

· Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.

• Reviews Standard Operating Procedure based on the actual activity.

· Ensures that all pertinent documents for Cosmetic are available for FDA inspection.

· Compiles and maintain complete technical data of each product by timely update of LTO's master file

· Prepares, compiles, and maintains up-to-date Product Information Files (PIF) in compliance with ASEAN Cosmetic Directive requirements and ensures their availability during audits or regulatory inspections.

OPERATIONS

· Ensures that formulation conforms to FDA standards and is within the approved limit.

• Ensures that labels of new and existing items conform to ACD Standards.

· Checking of e-Portal for newly approved CPNs. Download, file and update the Notifications Summary.

· Generates barcode and monitoring of registration on-line.

· Ensures that RGDI warehouses are complying with FDA requirements.

· Assists FDA inspector with the needs during inspection and makes sure that company is compliant.

• Conducts product tests for all finished goods distributed and imported by the company.

· Maintain current knowledge of relevant regulations in Cosmetic and keeping up to date with changes in regulatory legislation and guidelines.

• Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
• Coordinates the schedule of pest control in Marilao

SUPPLIERS

• Monitoring in conducting annual audits of all active suppliers.
• Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
• Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.

Qualifications:

• Graduate of Bachelor's Degree in Pharmacy and a licensed Pharmacist.
• At least one (2) year work related experience in regulatory and/or QA field.
• At least 1 year of experience in a supervisory or team lead role.
• Familiarity with Philippine FDA processes, portals, and documentation.
• Strong understanding of local and international regulations on cosmetics and wellness products.