Regulatory Affairs Officer
Full time
at Mondes International in
Mandaluyong City, Philippines
Job highlights
Posted on April 20, 2017- Professional background in
- Job level Junior/Entry Level
-
Pays salary of
PHP 18,000 - PHP 22,000 /month
(Fixed Salary)
Job details
PHARMACIST REGULATORY OFFICER Facilitates the Licensing and compliance to regulatory requirements mandated for cosmetics and other related product.
DUTIES AND RESPONSIBILITIES
• Ensure the company's licensing and compliance to legal requirements;
• Communicate closely with the regulatory authority for update in compliance requirements and advise the company for such update;
• Gather and prepare necessary documents for submission to, or as required by, the regulatory authority;
• Prepare submissions of license and certifications variations and application for their renewals, and set timelines for their approvals;
• Coordinate with relevant departments on quality systems and procedures, labeling requirements, product samples, and necessary documentation of the company required by the regulatory authority and other agencies;
• Arrange the inspection of the plant with the regulatory authority for licensing and certification;
• Inform the company regarding regulatory inspections;
• Recommend necessary preparations for the regulatory inspections;
• Comment on the company policies and practices that may influence on its compliance;
• Perform other activities that may be assigned by the company from time to time.
JOB QUALIFICATIONS:
• Must be a registered pharmacist
• At least six (6) months to one (1) year working experience is required in this position.
• Preferably familiar with FDA regulatory procedure and documentation, processing of Business permits, and other regulatory compliance.
• Willing to work in San Juan City
• Can start IMMEDIATELY.
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