Regulatory Affairs Associate

1 อัตรา

รายละเอียดคุณสมบัติ

Main Duties & Responsibilities Coordinate with colleagues, suppliers or clients to request (or support) the necessary documents and follow-up until finish. Prepare/ assist to prepare the submission documents for registration, renew, changing, etc. to support all business activities of company. Coordinate/ negotiate with TFDA or other authorities about submission, consulting, etc. and follow-up until approval or finish. Prepare/ recheck/ submit the FDA reports periodically as Thai regulation requirements. Participate and support IQA team to be good auditee and/or auditor. Perform other tasks as signed by Manager.   Requirements: Male/Female, age 22-30 years. Minimum 2 years of experience in regulatory affairs or pharmaceutical company. Bachelor of Sciences or related. Competent in English, Computer skill esp. Microsoft office, Internet searching etc., Good interpersonal skill, Confidence.