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Regulatory Affairs Associate
1 week ago
Job description
DETAILED DUTIES AND RESPONSIBILITIES:
1. FDA LTO (License To Operate), FCGMP (Certificate of Good Manufacturing Practice) Renewal
· Monitoring of all FDA LTO/FCGMP validity and expiration;
· Preparation of all FDA LTO/FCGMP forms and its supporting documents; and
· Request budget payment to Head Office for all FDA LTO/FCGMP renewal.
2. FDA CPR (Certificate of Product Registration)
· Monitor of all Company CPR validity and expiration;
· Prepare of FDA CPR Initial Registration Form based on approved Dossier from Regulatory Affairs Supervisor; and
· Email FDA on the request for online schedule of Dossier submission.
3. IPO (Intellectual Property Office)
· Monitor of all Company IPO validity and expiration;
· Prepare all related IPO (renewal & initial) documents and forms;
· Request budget payment to Head Office for all IPO initial and renewal.
· Facilitate in depositing IPO payment with accredited IPO banks.
4. BIO ASSAY (CEDRES)
· Monitoring of certificates validity and expiration;
· Checking of availability and process request of Active Pharmaceutical Ingredients (API) in Head Office;
· Facilitate request price quotation from CEDRES and request budget payment in Head Office;
· Checking of Finished Goods availability in company warehouse and stockroom;
· Request approval and release of Finished Goods sample from Product Manager;
· Prepares and submit all BIO ASSAY related documents and samples to CEDRES.
5. STOCK TRANSFER
· Collate Request Forms from Product Managers and request approval from Head Office;
· Prepares Delivery Receipt (DR) and schedule delivery and pick up from warehouse; and
· Monitor up to date stock inventory of all company products;
6. SHIPMENT
· Pre-alert coordination with Royal Cargo.
7. HOSPITAL INCLUSION AND GOVERNMENT BIDDING
· Preparation of required documents; and
· Coordinate with MSP Department for the completion of the required documents.
8. BUDGET REQUEST
· Prepares request of all department's budget payment to Head Office.
9. LOCAL PURCHASE OF SAMPLE
· Check availability and price of the sample product;
· Coordinate with Head office in relation to Invoices and Purchase Order; and
· Administer and monitor shipment of all purchased sample to Head Office.
QUALIFICATIONS
Must be registered Pharmacist.Willing to be assigned in Alabang, Muntinlupa.Can work independently with less supervisionAvailable to start anytimeFresh graduates are welcome.-
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