JOB OUTPUTS
· Complies and provide documents required by Food and Drug Administration and Bureau of animal Industry for registration and renewal of products
· Monitors and ensure validity of all Registered Licenses to Operate and Accreditations, Certificate of Product Registration and Exemption/ Clearance of products from appropriate government office/s
· To renew and ensure validity of Medical Director and Managing Director’s Licenses
· To assist acquisition of import permit for imported products
· To review packaging materials for printing
· To review posting of medical advertisement and subscription
· To initiate recall of products in case ordered by the manufacturer, handling of product complaints and monitoring/auditing of toll manufacturer
· To coordinate with the manufacturer regarding product registration and analysis
· Act as representative in meeting and seminars concerning regulatory functions
· Ensure GMP compliance of the company
· Conduct GMP training to new and regular employees associated to Good manufacturing and distribution Practice
· To ensure that all trademarks of the company are applied and declared the actual use
· Custodian of product dossier, manuscript and regulatory correspondence
· To assist in administrative functions in the office
TRAINING REQUIRED
· FDA GMP and licensing training
Skills
· Microsoft Office
· Above average communication skills