Regulatory Affairs Manager

3 days ago

Quezon City, National Capital Region, Philippines Direct Lines Sales Unltd. Inc. Full time ₱960,000 per year

We are looking for an experienced and detail-oriented Regulatory Affairs (RA) and Quality Assurance (QA) Manager to lead the implementation of company-wide quality systems and ensure full compliance with regulatory requirements.

This critical role involves managing audits, maintaining product quality, overseeing documentation, and serving as the primary liaison with regulatory agencies.

This position is ideal for professionals with a strong background in highly regulated industries such as pharmaceuticals, cosmetics, food, or medical devices.

Key Responsibilities

  • Develop, implement, and maintain company quality procedures, SOPs, and documentation systems.
  • Ensure full compliance with local and international regulations, including FDA, ISO, GMP, and other applicable standards.
  • Plan and conduct internal and external audits; manage third-party inspections and regulatory reviews.
  • Lead the investigation, documentation, and resolution of non-conformances; oversee corrective and preventive action (CAPA) processes.
  • Investigate and resolve customer complaints, ensuring appropriate documentation and follow-up.
  • Qualify and monitor suppliers to ensure ongoing compliance with company quality standards.
  • Lead and mentor the QA/RA team; conduct training programs to promote compliance and quality awareness across departments.
  • Manage product registration, labeling compliance, and coordinate all required regulatory submissions.
  • Track and analyze quality metrics; generate regular compliance and performance reports for senior management.

Qualifications:

  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
  • Minimum of 5 years in QA/RA roles, with increasing responsibilities in a regulated industry such as pharmaceuticals, medical devices, food, or cosmetics.
  • Deep understanding of FDA regulations, ISO standards, GMP practices, and end-to-end product lifecycle requirements.
  • Strong leadership and critical thinking abilities
  • Excellent documentation and organizational skills
  • Clear and effective communication across teams and regulatory bodies

Job Type: Full-time

Pay: Php60, Php80,000.00 per month

Work Location: In person

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