Prepares and check submission of License to Operate renewal and other inter-related regulatory correspondence with FDA.
Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.
Reviews Standard Operating Procedure based on the actual activity.
Ensures that all pertinent documents for Cosmetic, Food, Drug and Medical Device are available for FDA inspection.
Compiles and maintain complete technical data of each product by timely update of LTOs master file.
Ensures reliable IPO/Trademark monitoring
Assists in addressing all customer inquiries by providing retention and product test results within 2 working days upon request.
To ensure that product samples of new batches are distributed for testing 7 working days upon receipt.
To provide product testing to Purchasing Dept. 20 working days after product test distribution or before product release to the market (for urgent testing).
Ensures that formulation conforms to FDA standards and is within the approved limit.
Ensures that labels of new and existing items conform to FDA Standards.
Checking of e-Portal for newly approved CPN/CPRs. Download, file and update the Notifications Summary.
Generates barcode and monitoring of registration on-line.
Ensures that Vidamed warehouses are complying with FDA requirements.
Assists FDA inspector with the needs during inspection and makes sure that company is compliant.
Conducts product tests for all finished goods distributed and imported by the company.
Maintain current knowledge of relevant regulations in Cosmetic/Food/Medical device/Drugs and keeping up to date with changes in regulatory legislation and guidelines.
Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
Coordinates the schedule of pest control.
Monitoring in conducting annual audits of all active suppliers.
Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
Conducts a Product Information File for filing based on ASEAN Cosmetic Directive.
Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.
Perform other related duties as required by FDA and other tasks assigned as needed.
