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Regulatory Affairs and Quality Assurance Supervisor

2 weeks ago

Pasig, National Capital Region, Philippines Hovid Full time $60,000 - $80,000 per year

JOB SUMMARY:The position shall primarily handle regulatory, and quality assurance matters of Hovid, Inc. particularly updating and renewal of all licenses pertaining to Company's operations that will comply with the regulatory authorities (FDA) in the Philippines and investigation and resolution of quality issues, including identifying root causes and implementing corrective and preventive actions. Maintaining up-to-date knowledge of relevant regulations and industry standards. KEY RESPONSIBILITIES: 1.

Regulatory Affairs

  • Ensures that all products produced are registered and in compliance with regulatory requirements prescribed by the Food and Drug Administration (FDA) and other applicable regulatory agencies.
  • Submits dossiers for initial registration and ensures that all technical documentary requirements are in accordance with FDA
  • Approves artwork of packaging materials of products subject for registration in accordance with FDA labeling requirements/guidelines (including promotional materials);
  • Manage up to date compliance of all letters from FDA specifically product NOD and other deficiency if any.
  • Manage application of licenses to FDA as well as its on-time renewal.
  • Maintains and manage all records (database) of certificate of product registration, LTO's and CGMP for all products being distributed by Hovid Inc. (Drugs, Food, Medical Devices, Cosmetics, HUHS).
  • Follows up all pending applications to FDA via email, or phone call according to FDA timeline/citizen's charter.
  • Attend FDA seminar in all matters pertaining to product registration and operation/s of pharmaceutical company.
  • Performs other tasks that may be assigned by the Immediate Superior from time to time.2.

Quality Assurance

  • Manage and maintain company's quality assurance documentation and records.
  • Assists quality inspection of incoming shipments and reports any non-compliance to the management and to the head office (shipper and or supplier).
  • Monitor and ensures all products being repacked/redressed by third party service provider/s are compliant with the approved artwork and/or promo permit.
  • Handles customer complaints related to product quality and coordinates with concerned departments/business partners for the resolution of such issues.
  • Conducts regular meetings with stakeholders to provide updates and timelines regarding deficiencies.
  • Evaluate the corrective actions taken for the non-conformance noted during inspection of local government units (FDA).
  • Ensure the top management is fully aware of any high-risk concerns due to deficiencies of any inspection done.
  • The driver and safe keeper for all departments' SOP & Processes.

Assist all departments with process improvementQUALIFICATION REQUIREMENTS:1. Bachelor's Degree in Pharmacy or related field, PRC License required;2. Minimum of 5 years' experience in Regulatory Affairs and Quality Assurance in a pharmaceutical company;3.

Experience working with FDA and regulatory bodies in dossier submission, GMP audits and compliance;FUNCTIONAL COMPETENCIES1. In-depth knowledge of pharmaceutical regulations, GMP, GDP, QMS, etc.2. Strong understanding of quality assurance, principles, risk assessment and audit processes;3.

Familiarity with pharmacovigilance requirements and adverse event reporting;4. Excellent communication and negotiation skills;5. Strong analytical and problem-solving skills;6.

Ability to manage multiple projects and meet deadlines;7. Leadership skills to rain and guide teams on complianceWORK ENVIRONMENT

  • Blended office-based and field-based; composed of documents preparation, submission, collaboration with regulatory agencies & sub-distributors, quality checking of shipments and repacking productions.