Job Details
Skills And Tools:
Job Description
Document Review and Submission:
- Review all documentation to ensure accuracy and completeness before submission to the Drug Authority.
- Upload necessary files on the official Drug Authority portal and maintain submission records.
- Deliver hard copies of submitted documents to the Drug Authority and obtain acknowledgment receipts.
2. Follow-Up and Monitoring:
- Monitor administrative progress of submissions through department tracking sheets.
- Regularly communicate with regulatory bodies to resolve any queries or challenges.
3. Cross-Functional Coordination:
- Collaborate with internal departments such as Quality Assurance, Marketing, and Supply Chain to gather and align required documentation.
- Coordinate with the Drug Authority across multiple divisions to address issues and expedite approvals.
4. Compliance Management:
- Ensure all products meet local and international regulatory requirements.
- Stay updated on changes to regulatory guidelines and implement necessary updates.
5. Relationship Management:
- Build and maintain professional relationships with officials at the Drug Authority.
- Attend regulatory workshops and training sessions to enhance knowledge and stay updated.
Job Requirements
- Bachelor’s degree in Pharmacy, Science, or Veterinary Medicine or any related field.
- Minimum of 1 : 3 years of experience in regulatory affairs.
- Proficiency in computer usage, particularly regulatory portals and documentation tools.
- Strong analytical and communication skills.
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