Duties and Responsibilities:
Prepare the documentation for new product registration, update & renewal of existing product licenses, and KGMP certifications with MFDS; Assist in filing and maintaining product and establishment registrations with QIA, animal health regulatory authority; Communicate with ASEAN regional counterparts to coordinate registration strategies and support new product registration, update & renewal of existing product licenses, and compliance to local quality requirements; Assist in communications with regional regulatory representatives to assist in filings and responses to inquiries from health authorities and notified bodies in ASEAN region; Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements in ASEAN region; Maintain up-to-date knowledge on domestic and ASEAN region’ regulatory requirements and provide ...