Regulatory Affairs

1 day ago

Santolan Metro Manila, Philippines Icon Executive Asia Full time ₱1,200,000 - ₱3,600,000 per year

Job Title: Regulatory Affairs & Quality Manager

Work Location: Libis, Quezon City and Santolan, Pasig City (Onsite)

Work Schedule: Monday to Friday | 8:00 AM – 5:30 PM

Target Onboarding Date: ASAP

Employment Type: Full-Time | Onsite

Job Overview:

  • We are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) Manager to oversee and implement company-wide quality systems and ensure strict compliance with regulatory requirements. This role is critical in managing internal audits, product quality, and documentation, while serving as the key liaison with regulatory agencies. Ideal for professionals with solid experience in highly regulated industries such as pharmaceuticals, cosmetics, food, or medical devices.

Key Responsibilities:

  • Quality Systems Implementation: Develop and maintain quality control procedures, SOPs, and documentation.

  • Regulatory Compliance: Ensure company operations meet local and international standards (FDA, ISO, GMP, etc.).

  • Audit Management: Conduct internal/external quality audits and oversee third-party inspections.
  • CAPA & Non-Conformance Management: Lead corrective and preventive actions and manage non-conforming products.
  • Customer Complaint Handling: Investigate, document, and resolve product or service-related complaints.
  • Vendor & Supplier Quality Oversight: Manage supplier qualification and monitor ongoing compliance with quality standards.
  • Team Leadership: Supervise and mentor QA/RA staff; lead training programs on compliance and quality systems.
  • Regulatory Submissions: Coordinate product registration, labeling, and other submissions to regulatory bodies.
  • Data Analysis & Reporting: Analyze quality metrics and prepare regulatory reports for senior management.

Qualifications & Skills:

    • Education: Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.

  • Experience:

  • At least 5 years of progressive experience in QA/RA management in a regulated industry (e.g., pharmaceuticals, medical devices, food, cosmetics).

  • Technical Knowledge: Solid understanding of FDA regulations, ISO standards, GMP practices, and product lifecycle requirements.
  • Soft Skills: Strong leadership, critical thinking, documentation, and communication skills.
  • Tools & Systems: Proficiency in MS Office, Quality Management Systems (QMS), and regulatory databases.

Compensation & Benefits:

  • Monthly Salary: Up to ₱80,000
  • Allowance: Communication allowance
  • Bonuses: 13th Month Pay
  • HMO: Provided upon hire

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