เภสัชกรขึ้นทะเบียนยา กลุ่มยาใหม่ ยาสามัญใหม่
Innomedilab Co.,Ltd.1.Prepare and submitting of ACTD dossier for new drug, new generic drug. Support oversea partners to acquire and prepare ACTD. 2.Prepare and submitting of CSDT for complicated medical device. 3.Support oversea partner for documents preparation. 4.Prepare a report of product registration status, problem, suggest solution and action plan to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. 5.Provide regulatory guidance to related departments, project developing teams regarding design, development and marketing of products. 6.Supported related department to prepare label, package insert, patient insert leaflet, promotional material. 7.Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced 8.Prepare risk management plan, implement and follow up Pharmacovigilance. 9.Develop local RA staff, document system and maintain standard operating procedures.
7. Able to communicate in English. 8. Good command in MS. Office and computer skill
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันอุบัติเหตุ
- มีเวลาการทำงานที่ยืดหยุ่น