Licensed Pharmacist for Regulatory Affairs

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Early Applicant

Job Description

Ensure that the company's products comply with FDA regulations
Prepare documents for timely submission of Licenses of Product Registration (Initial, Renewal and Variation) applications
Prepare documents for Cosmetic Notification application
Responsible for the renewal of PhilGEPS membership
Write clear, accessible product labels and patient information leaflets
Review packaging lay outs and promotional materials in line with the existing standards set by FDA
Specific storage, labeling and packaging requirements
Coordinate with FDA , DOH, IPO, PhilGEPS and other government agencies on a regular basis or as deemed necessary
Negotiate with regulatory authorities for marketing organization
Keep abreast of international legislation , guidelines and customer practices
Other tasks will be discussed during interview