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 (1) 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.

Job Type: Full-time

Benefits:

• Company events
• Health insurance
• Opportunities for promotion
• Promotion to permanent employee

License/Certification:

• PRC license (Preferred)

Work Location: In person