Regulatory Affairs

4 days ago


Marilao, Central Luzon, Philippines Lifestrong Marketing Inc. Full time $104,000 - $130,878 per year

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

Work Location: In person


  • Regulatory Affairs

    4 days ago


    Marilao, Central Luzon, Philippines Lifestrong Marketing Inc. Full time $40,000 - $80,000 per year

    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...


  • Marilao, Central Luzon, Philippines Lifestrong Marketing Inc. Full time ₱900,000 - ₱1,200,000 per year

    ResponsibilitiesQUALITY 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 StandardsSupervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other...


  • Marilao, Central Luzon, Philippines Lifestrong Marketing Inc. Full time $40,000 - $60,000 per year

    Graduate of Bachelor's Degree in Pharmacy and a licensed Pharmacist.At least 1 year of experience in a supervisory or team lead role.Familiarity with Philippine FDA processes, portals, and documentation.Excellent written and verbal communication skills.High attention to detail, with strong organizational and project management skills.Knowledgeable of quality...


  • Marilao, Philippines Lifestrong Marketing Inc. Full time

    Regulatory Affairs and Quality Assurance Supervisor 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 enforce Good Manufacturing Practices and other...