Regulatory Affairs Specialist

3 days ago


Manila, National Capital Region, Philippines Manpower Philippines Full time

Job Description:

The Regulatory Affairs & QA Specialist is responsible for ensuring the company's compliance with regulatory requirements and maintaining good relationships with government agencies.

Key Responsibilities:

  • Maintains professional relationships with government regulatory agencies
  • Secures documents and materials needed for product registration
  • Manages filing and retrieval system of pharmaceutical regulatory affairs documents
  • Obtains and renews necessary Government licenses, product registrations and permits
  • Liaises regularly with regulatory authorities in the Philippines
  • Represents the department on global and local project teams
  • Coordinates and checks product literature, label and other packaging components
  • Responds to pharmacovigilance reports and feedbacks
  • Manages proper documentation and closure on Change Notifications
  • Prepares artwork for ZPI products, e.g., labels, package inserts and other commercial facsimile presentations

  • regulatory affairs

    3 days ago


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