PHARMACIST (GENERAL)

Regulatory Affairs Pharmacist

• Ensures timely application and finalize preparation of documents for initial, renewal, amendment, PCPR and CLIDP product registration to FDA and all the necessary compliances associated to it during the application process (if applicable) at the same time ensure completeness and correctness of documents prior to checking and approval of Supervisors and Managers.
• Prepares documents needed for application of licenses and/or legal compliances such as CPR’s and permits from FDA, PDEA or any government agencies.
• Prepares and submit batch notification documents to FDA for antibiotic products upon full completion of the batch as endorsed by QA Unit, Update reports upon receipt of the batch Notification approval from FDA
• Prepares and routes memo for the CPR receive whether initial, renewal, amendment, PCPR, CLIDP and ensure that notification of change is attach for whatever changes is being made/done.
• Regularly updates the database for CPR application tracking and CPR master list.
• Performs daily monitoring of FDA website for latest advisories and report to Supervisor for proper dissemination and evaluate and asses the impact of any FDA or regulatory memos, circulars or notices to the organization through a written memo or email.
• Provide Assistance to Regulatory Affairs/pharmacists of clients when required.
• Practice integrity in all business transactions most especially when representing the organization to regulatory agencies