Drug Regulation and Compliance Manager
5 days ago
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.
- Verify that artwork complies with all regulatory standards and requirements.
- Foster effective communication between Medethix Inc's regulatory team and external suppliers to resolve dossier-related issues.
- Review and validate dossiers for various regulatory submissions, ensuring accurate and complete documentation.
- Develop and finalize artwork for these applications as needed.
- 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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