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. #J-18808-Ljbffr