Drug Regulation and Compliance Manager

5 days ago


Manila, National Capital Region, Philippines Medethix Inc Full time

The Regulatory Pharmacist at Medethix Inc functions as a key member of the regulatory team, overseeing the review and evaluation of dossiers for high-priority products. This position demands a deep understanding of Philippine FDA regulations and excellent communication skills to manage supplier relationships and support regulatory officers.

Main Responsibilities:

Dossier Review and Evaluation:
  • Conduct detailed assessments of dossiers to identify areas for improvement.
  • Cultivate strong relationships with suppliers to obtain additional information and clarify dossier content discrepancies.
Artwork Preparation:
  • Verify that artwork complies with all regulatory standards and requirements.
Supplier Coordination:
  • Foster effective communication between Medethix Inc's regulatory team and external suppliers to resolve dossier-related issues.
Initial Registration, Monitored Release Registration, Variation Applications, and Notifications:
  • Review and validate dossiers for various regulatory submissions, ensuring accurate and complete documentation.
  • Develop and finalize artwork for these applications as needed.
Support to Operations:
  • Collaborate with peers to prepare and submit dossiers efficiently and accurately.
  • Manage a comprehensive database of regulatory activities and submissions.

Core Qualifications:

  • Registered pharmacist licensure
  • Background in regulatory affairs within the pharmaceutical industry (1-2 years)
  • Extensive knowledge of Philippine FDA regulations and submission processes
  • Outstanding organizational and analytical skills
  • Proficiency in Microsoft Office or Google Workspace applications and database management
  • Excellent interpersonal and communication abilities


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