FDA Regulatory Officer
2 weeks ago
The FDA/ Regulatory Officer responsible for gathering, monitoring, finalizing, encoding and filing necessary data submitted and/or received from FDA (FDA Liaison Officer and Coordinating Officer). Supports the company in ensuring compliance with international and local regulatory standards.
Responsibilities:
- Coordinate with foreign suppliers for FDA requirements
- Checking documents if complied with FDA regulatory
- Apply CPR in the portal/ Website
- Monitoring near CPR expiry for renewal
- Check product for: Initial and Amendment
- Application & renewal of Certificate of Product Registration. Ensure the company's timely and proper compliance to FDA
- Collaborate and communicate with foreign suppliers for the required documentation (if complied with FDA regulatory)
- Maintain accurate records and documentation needed.
Qualifications:
- Must have good analysis of the information of the products & data input to FDA.
- Must have good communication skills.
- Graduate of any 4 years course and exposure in Logistics, Operations and Distribution.
- Experience with FMCG is a plus.
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